Every finding on record at All Americans Choice Home Health Inc

The following reflects the findings of the California Department of Public Health during a recertification survey conducted June 1, 2026, through June 4, 2026. Census: 132 Unduplicated Admissions: 209 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 All Conditions of Participation were met.

The following reflects the findings of the California Department of Public Health during a recertification survey conducted June 1, 2026, through June 4, 2026. Census: 132 Unduplicated Admissions: 209 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 The following Conditions of Participation were not met: G 570 §484.60 Care planning, coordination of services, and quality of care G 640 §484.65 Quality assessment and performance improvement (QAPI) G 680 §484.70 Infection prevention and control G 940 §484.105 Organization and administration of services

Have a confidential clinical record CFR(s): 484.50(c)(6) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure personal health information were kept confidential for one (1) of 3 (three) sampled Patients (Patient 1) for home visits when one Registered Nurse (RN 1) received and sent Patient 1’s clinical records using her personal cell phone. This failure resulted in Patient 1’s personal health information being put at risk by not keeping health records confidential, and using personal equipment not being monitored and secured by the agency. Findings: During a review of Patient 1’s face sheet (contains demographic and medical information), undated, indicated Patient 1’s start of care date of April 15, 2026, with a certification period of April 15, 2026, to June 13, 2026. Patient 1 had diagnosis which included aftercare following hip joint replacement surgery (removes damaged bone and cartilage in the hip joint and replace them with artificial medical devices). During a concurrent home visit observation and interview on June 2, 2026, at 10:30 AM, with RN 1, RN 1 took Patient 1’s surgical wound photo with her personal cell phone. RN 1 verified and confirmed she uses her personal cell phone to send and receive Patient 1's confidential information to the agency without using a secure app, RN 1, further stated that the agency has never provided any secure app to send or receive patients’ confidential information. During an interview on June 3, 2026, at 11:30 AM with the Administrator/Director of Patient Care Services (ADMIN/DPCS), the ADMIN/DPCS confirmed the agency does not use any secure app to send or receive patient’s confidential information, agency staff use their personal cell phones to send and receive patient confidential information. During a concurrent interview and record review on June 3, 2026, at 3:10 PM, with the ADMIN/DPCS, the facility’s undated Policy and Procedure (P&P), titled, “PATIENT PRIVACY RIGHTS," dated November 2023, was reviewed. The P&P indicated, "...Will respect and safeguard all protected health information of the patients it serves…DEFINITION-Protected health Information (PHI) is any information about health status, provision of health care, or payment for health care that can be linked to a specific individual in ANY form (verbal, written, electronic)." The ADMIN/DPCS stated the agency did not follow the P&P.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: The agency failed to ensure the Condition of Participation: G 570 §484.60 care planning, coordination of services, and quality of care was in compliance when: 1. Based on interview and record review, the agency failed to ensure a physician reviewed and signed the patients' plans of care (a document that provides direction on the type of clinical care a patient needs) within 30 working days of the patients' start of care as required by State law and the agency's policy and procedure, titled “Physician Participation in Plan of Care,” dated November 2023, for five of seven sampled patients (Patients 1, 2, 3, 6, and 7). (Refer to G 572) 2. Based on interview and record review, the agency failed to ensure the physicians reviewed and signed verbal orders (a directive given by a doctor orally, either in person or over the phone) within 30 working days of the date of the order as required by State law and the agency's policy and procedure titled “Verification of Physician Orders," dated November 2023, for four of seven sampled patients (Patients 2, 3, 6 and 7). (Refer to G 584) The cumulative effect of these systemic practices had the potential to jeopardize patient safety by allowing care to be delivered without timely physician oversight, increasing the risk of unsafe, uncoordinated, or clinically inappropriate services throughout the agency.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure a physician reviewed and signed the patients' plans of care (a document that provides direction on the type of clinical care a patient needs) within 30 working days of the patients' start of care as required by State regulation and the agency's policy and procedure (P&P) titled, “Physician Participation in Plan of Care,” dated November 2023, for five of seven sampled patients (Patients 1, 2, 3, 6, and 7). This failure had the potential to cause delays in physician oversight of the plan of care, which could result in uncoordinated services and unmet needs for sampled Patients 1, 2, 3, 6, and 7. Findings: 1. A review of Patient 1’s plan of care, undated, indicated a start of care date of April 15, 2026, with a certification period of April 15, 2026, to June 13, 2026. Patient 1 had diagnosis which included aftercare following hip joint replacement surgery (removes damaged bone and cartilage in the hip joint and replace them with artificial medical device). A review of Patient 1’s plan of care/physician order dated April 15, 2026, to June 13, 2026, was conducted on June 4, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Fifty days had passed without a physician review and signature). During an interview with the Administrator/Director of Patient Care Services (ADMIN/DPCS) on June 4, 2026, at 9:00 AM, the ADMIN/DPCS stated it was her responsibility to ensure the patients’ plans of care were reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. The ADMIN/DPCS verified Patient 1’s plan of care was not reviewed, approved, and signed by a physician within 30 days of Patient 1’s start of care. 2. A review of Patients 2’s plan of care, undated, indicated a start of care date of March 30, 2026, with a certification period of March 30, 2026, to May 28, 2026. Patient 2 had diagnosis which included essential hypertension (persistently high blood pressure that is not caused by an underlying medical condition), and generalized muscle weakness. A review of Patient 2’s plan of care/physician order dated March 30, 2026, to May 28, 2026, was conducted on June 4, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Sixty-six days had passed without a physician review and signature). During an interview with the Administrator/Director of Patient Care Services (ADMIN/DPCS) on June 4, 2026, at 9:10 AM, the ADMIN/DPCS stated it was her responsibility to ensure the patients’ plans of care were reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. The ADMIN/DPCS verified Patient 2’s plan of care was not reviewed, approved, and signed by a physician within 30 days of Patient 2’s start of care. 3. A review of Patient 3’s plan of care, undated, indicated a start of care date of April 1, 2026, with a certification period of April 1, 2026, to May 30, 2026. Patient 3 had diagnoses which included obstructive and reflux uropathy (a condition where a urinary tract blockage forces urine to flow backwards into the kidneys), and urinary tract infection (a bacterial infection in the urinary system). A review of Patient 3’s plan of care/physician order dated April 1, 2026, to May 30, 2026, was conducted on June 4, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (sixty-four days had passed without a physician review and signature). During an interview with the Administrator/Director of Patient Care Services (ADMIN/DPCS) on June 4, 2026, at 9:20 AM, the ADMIN/DPCS stated it was her responsibility to ensure the patients’ plans of care were reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. The ADMIN/DPCS verified Patient 3’s plan of care was not reviewed, approved, and signed by a physician within 30 days of Patient 3’s start of care. 4. A review of Patient 6’s plan of care, undated, indicated a start of care date of February 10, 2026, with a certification period of February 10, 2026, to April 10, 2026. Patient 6 had diagnosis which included hepatic encephalopathy (a decline in brain function that occurs due to severe liver disease). A review of Patient 6’s plan of care/physician’s order dated February 10, 2026, to April 10, 2026, was conducted on June 3, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Seventy-eight working days had passed without a physician’s review and signature). 5. A review of Patient 7’s plan of care, undated, indicated a start of care date of January 20, 2026, with a certification period of January 20, 2026, to March 20, 2026. Patient 7 had diagnosis which included hypertensive heart disease with heart failure (heart damage caused by long-term high blood pressure that thickens and stiffens the heart muscle, weakening its ability to pump blood and leading to heart failure). A review of Patient 7’s plan of care/physician’s order dated January 20, 2026, to March 20, 2026, was conducted on June 3, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Ninety-three working days had passed without a physician’s review and signature). During an interview with an Intake Coordinator (IC), the Administrator/Director of Patient Care Services (Admin/DPCS), and the Owner/Administrator Designee (Owner/AD) on June 3, 2026, at 3:15 PM, the IC stated he electronically faxed (e‑faxed) the physicians their patient’s plans of care/physician’s orders, but it would take months to receive the plans of care/physician’s orders back with the physician’s signatures. The IC stated he had discussed the problem with management but had not received direction to do anything differently than the e‑fax. The Admin/DPCS and Owner/AD stated they received all of their patients from one Acute Care Hospital (ACH), and they had a continual problem getting the plans of care/physician’s orders signed by the physicians referring the patients to the home health agency. The Admin/DPCS stated she was aware the regulatory requirement required the patients’ plans of care/physician’s orders to be reviewed and signed by the physician within 30 working days but had not brought the problem to the attention of the Quality Assessment and Performance Improvement (QAPI) Program, and there was no action plan to address the problem. A review of Title 22: § 74697 (State regulations that has a comprehensive set of rules. It establishes the baseline legal and safety standards for healthcare facilities) Plan of Treatment; Plan of Care; Plan for Personal Care Services, indicated, “(a) A written plan of treatment (or plan of care for home health agencies participating in the Medicare and/or Medi-Cal program) shall be established for each patient whose care requires medical orders. A plan of treatment or plan or care for patients requiring medical orders shall be: (1) Approved and signed within 30 working days by the attending physician, dentist, podiatrist. or other licensed and legally authorized practitioner within his or her scope of practice.” A review of the agency's policy and procedure (P&P) titled, “Physician Participation in Plan of Care,” dated November 2023, indicated, “PURPOSE: To provide guidelines for the physician's (or other authorized licensed independent practitioner's) participation in home health care services. POLICY: A physician (or other authorized licensed independent practitioner) will direct the care of every home health care patient admitted for service. The attending physician (or other authorized licensed independent practitioner) will certify that medical, skilled, rehabilitative, and social services provided by the organization are medically necessary and meets the requirements to be covered by Medicare. The attending physician (or other authorized licensed independent practitioner) will participate in the care planning process by initiating, reviewing and revising therapeutic and diagnostic orders. The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practice. … PROCEDURE: … The attending physician (or other authorized licensed independent practitioner) will sign the plan of care/treatment within 30 days of the start of care. …”

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the physicians reviewed and signed verbal orders (a directive given by a doctor orally, either in person or over the phone) within 30 working days of the date of the order as required by State regulation and the agency's policy and procedure (P&P) titled, “Verification of Physician Orders,” dated November 2023, for four of seven sampled patients (Patients 2, 3, 6 and 7). This failure had the potential to cause delays in implementing accurate physician‑directed care, increasing the risk of receiving incorrect, outdated, or unsafe treatments for Patients 2, 3, 6, and 7. Findings: 1. A review of Patient 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of March 30, 2026, with a certification period of March 30, 2026, to May 28, 2026. Patient 2 had diagnoses which included essential hypertension (persistently high blood pressure that is not caused by an underlying medical condition), and generalized muscle weakness. a. Patient 2’s admission order dated April 8, 2026. (fifty-seven days had passed without physician's signature). b. Patient 2’s verbal order dated April 8, 2026, indicated CHHA (certified home health aide) visit frequencies of one time a week for eight weeks. (fifty-seven days had passed without physicians’ signature). c. For Patient 2, the care plan did not include CHHA visits frequencies and was not reviewed, approved, and signed by a physician within 30 days of the patient’s resumption of care. During an interview with the Administrator/Director of Patient Care Services (ADMIN/DPCS) on June 4, 2026, at 9:35 AM, the ADMIN/DPCS verified Patient 2’s, CHHA visit frequency order had not been signed by the physician within 30 working days. 2. A review of Patient 3’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 1, 2026, with a certification period of April 1, 2026, to May 30, 2026. Patient 3 had diagnoses that included obstructive and reflux uropathy (a condition where a urinary tract blockage forces urine to flow backwards into the kidneys), and urinary tract infection (a bacterial infection in the urinary system). a. Patient 3’s admission order dated April 1, 2026, to May 30, 2026 (sixty-four days had passed without a physician review and signature). b. Patient 3’s verbal order dated March 31, 2026, indicated Physical Therapy (PT) for evaluation and treatment (sixty-five days had passed without physicians’ signature). c. For Patient 3, the care plan did not include PT evaluation and treatment visit and was not reviewed, approved, and signed by a physician within 30 days of the patient’s resumption of care. During an interview with the Administrator/Director of Patient Care Services ADMIN/DPCS) on June 4, 2026, at 9:45 AM, the ADMIN/DPCS verified Patient 3’s PT visit frequency order had not been signed by the physician within 30 working days. 3. A review of Patient 6’s plan of care, undated, indicated a start of care date of February 10, 2026, with a certification period of February 10, 2026, to April 10, 2026. Patient 6 had diagnoses that included hepatic encephalopathy (a decline in brain function that occurs due to severe liver disease). A review of Patient 6’s verbal physician orders on June 3, 2026, was conducted. There was no documented evidence to show the following verbal physician orders had been signed by a physician: a. Admission order dated February 6, 2026. (Eighty working days had passed without a physician’s signature). b. Transfer to inpatient facility dated February 12, 2026. (Seventy-four working days had passed without a physician’s signature). c. Discharge while inpatient dated February 26, 2026. (Sixty working days had passed without a physician’s signature). 4. A review of Patient 7’s plan of care, undated, indicated a start of care date of January 20, 2026, with a certification period of January 20, 2026, to March 20, 2026. Patient 7 had diagnoses that included hypertensive heart disease with heart failure (heart damage caused by long-term high blood pressure that thickens and stiffens the heart muscle, weakening its ability to pump blood and leading to heart failure). A review of Patient 7’s verbal physician orders on June 3, 2026, was conducted. There was no documented evidence to show the following verbal physician orders had been signed by a physician: a. Discharge Patient dated February 13, 2026. (Seventy-three working days had passed without a physician’s signature). During an interview with an Intake Coordinator (IC), the Administrator/Director of Patient Care Services (Admin/DPCS), and the Owner/Administrator Designee (Owner/AD) on June 3, 2026, at 3:15 PM, the IC stated he electronically faxed (e‑faxed) the physicians their patient’s plans of care/physician’s orders, but it would take months to receive the plans of care/physician’s orders back with the physician’s signatures. The IC stated he had discussed the problem with management but had not received direction to do anything differently than the e‑fax. The Admin/DPCS and Owner/AD stated they received all of their patients from one Acute Care Hospital (ACH), and they had a continual problem getting the plans of care/physician’s orders signed by the physicians referring the patients to the home health agency. The Admin/DPCS stated she was aware the regulatory requirement required the patients’ plans of care/physician’s orders to be reviewed and signed by the physician within 30 working days but had not brought the problem to the attention of the Quality Assessment and Performance Improvement (QAPI) Program, and there was no action plan to address the problem. A review of Title 22: § 74697 (State regulations that has a comprehensive set of rules. It establishes the baseline legal and safety standards for healthcare facilities) Plan of Treatment; Plan of Care; Plan for Personal Care Services, indicated, “(a) A written plan of treatment (or plan of care for home health agencies participating in the Medicare and/or Medi-Cal program) shall be established for each patient whose care requires medical orders. A plan of treatment or plan or care for patients requiring medical orders shall be: (1) Approved and signed within 30 working days by the attending physician, dentist, podiatrist. or other licensed and legally authorized practitioner within his or her scope of practice.” A review of the agency's policy and procedure (P&P) titled, “Verification of Physician Orders,” dated November 2023, indicated, “PURPOSE: To ensure that accurate physician (or other authorized licensed independent practitioner) orders are obtained in accordance with applicable law and regulation. POLICY: Orders will be obtained from a licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients. … PROCEDURE: 1. An order or prescription will be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy if permitted by law, or the direct transcription of a verbal order. 2. All telephone orders will be received and processed in accordance with state and federal laws and regulations. 3. All telephone orders or verbal orders will be "read back" to the physician (or other authorized licensed independent practitioner) or designee to assure accuracy. 4. Orders will be documented on a form provided by [name of the agency] dated and signed by the professional receiving the order. 5. A copy of the physician's (or other authorized licensed independent practitioner's) order will be kept in the clinical record. 6. The original of the order form will be delivered to the physician (or other authorized licensed independent practitioner) for signature. 7. When the signed order form is returned to [name of the agency], the copy will be removed from the clinical record and destroyed, and the original will be retained in the clinical record. 8. Signed orders will be in the clinical record within 30 days of initiation of care or interim order, unless otherwise specified by applicable state law and regulation.”

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: The agency failed to ensure that the Condition of Participation: G 640 484.65 Quality assessment and performance improvement (QAPI - a system wide improvements with standard setting to elevate patient safety and care quality) was in compliance as follows: 1. Based on interview and record review, the agency failed to measure, analyze, and track quality indicators to assess processes of care, agency services, and operations from January 2024 to June 4, 2026, for Patients 1 to 132. Although the agency reported reviewing infections and falls, the agency did not ensure the accuracy of infection data, did not measure or analyze fall data, and did not identify or monitor other high risk, high volume, or problem‑prone areas as required. (Refer to G 642) 2. Based on interview and record review, the agency failed to conduct QAPI program activities required to identify, analyze, and improve high‑risk, high‑volume, and problem‑prone areas from January 2024 through June 4, 2026, for Patients 1 to 132, when it did not ensure accurate infection data, did not measure or analyze fall data, and focused its QAPI efforts primarily on reducing rehospitalizations without tracking or trending whether those rates decreased, remained the same, or increased. The agency also failed to identify or monitor other high‑risk, high‑volume, or problem‑prone areas needed to assess performance across the spectrum of care. (Refer to G 646) 3. Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP – a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP, and measurable goals to show progress achieved, from January 2024 to June 4, 2026, for Patients 1 to 132. (Refer to G 658) 4. Based on interview and record review, the agency’s Governing Body (GB- a group of individuals vested with the ultimate authority, power, and responsibility to guide an organization, guide policy, and make binding decisions) failed to ensure that an ongoing Quality Assessment and Performance Improvement (QAPI) Program addressed priorities for improved quality of care and patient safety, and the GB failed to evaluate all improvement actions for effectiveness from January 2024 through June 4, 2026, for Patients 1 through 132, when: a. The agency failed to measure, analyze, and track quality indicators to assess processes of care, agency services, and operations from January 2024 to June 4, 2026, for Patients 1 to 132. Although the agency reported reviewing infections and falls, the agency did not ensure the accuracy of infection data, did not measure or analyze fall data, and did not identify or monitor other high risk, high volume, or problem‑prone areas as required. (Refer to G 660) b. The agency failed to conduct QAPI program activities required to identify, analyze, and improve high‑risk, high‑volume, and problem‑prone areas from January 2024 through June 4, 2026, for Patients 1 to 132, when it did not ensure accurate infection data, did not measure or analyze fall data, and focused its QAPI efforts primarily on reducing rehospitalizations without tracking or trending whether those rates decreased, remained the same, or increased. The agency also failed to identify or monitor other high‑risk, high‑volume, or problem‑prone areas needed to assess performance across the spectrum of care. (Refer to G 660) c. The agency failed to conduct and document performance improvement projects (PIP – a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP, and measurable goals to show progress achieved, from January 2024 to June 4, 2026, for Patients 1 to 132. (Refer to G 660) The cumulative effect of these systemic practices prevented the GB from ensuring the implementation and oversight of an effective, comprehensive, and data‑driven QAPI program, thereby undermining the agency’s ability to ensure the provision of safe, effective, and quality care and to prevent, identify, and correct adverse events and performance problems affecting Patients 1 to 132.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to measure, analyze, and track quality indicators to assess processes of care, agency services, and operations from January 2024 to June 4, 2026, for Patients 1 to 132. Although the agency reported reviewing infections and falls, the agency did not ensure the accuracy of infection data, did not measure or analyze fall data, and did not identify or monitor other high risk, high volume, or problem‑prone areas as required. This failure had the potential to cause delays in identifying and addressing patient infections, patient falls, and other high risk, high volume, or problem‑prone areas because the agency did not measure, analyze, or track these indicators within its quality assessment and performance improvement processes for Patients 1 to 132. Findings: During a review of the Quality Assessment and Performance Improvement (QAPI - a system wide improvements with standard setting to elevate patient safety and care quality) Program on June 2, 2026, the Administrator/Director of Patient Care Services (Admin/DPCS) provided the annual QAPI committee minutes dated January 10, 2025, for the review of the 2024 QAPI Program; the annual QAPI committee minutes dated January 9, 2026, for the review of the 2025 QAPI Program; and the annual QAPI committee minutes dated May 29, 2026, for the review of the 2026 QAPI Program to date. 1. A review of the QAPI committee minutes dated January 10, 2025, indicated: a. “Infection Control Program. Findings reviewed: Zero patient infections. Zero healthcare‑associated infections. Zero employee exposure incidents. Zero communicable disease outbreaks. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” b. “Fall Prevention Program. Findings reviewed: Two reported patient falls. No major injuries. No fractures. No fall‑related deaths. No repeat fallers. Committee Determination: The Fall Prevention Program remains effective with continued monitoring recommended.” c. No other high risk, high volume, or problem‑prone areas were identified. 2. A review of the QAPI committee minutes dated January 9, 2026, indicated: a. “Infection Prevention and Control Program. Findings reviewed: Zero patient infections. Zero healthcare‑associated infections. Zero employee exposure events. Zero communicable disease outbreaks. Zero infection‑related hospitalizations. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” b. “Fall Prevention and Incident Management Program. Findings reviewed: Zero reported falls. Zero fall‑related injuries. Zero fractures. Zero fall‑related hospitalizations. Zero repeat fallers. Committee Determination: The Fall Prevention Program was determined to be highly effective.” c. No other high risk, high volume, or problem‑prone areas were identified. 3. A review of the QAPI committee minutes dated May 29, 2026, indicated: a. “Infection Prevention and Control Program … Findings: Zero infections.” b. “Fall Prevention Program … Findings: … Three falls (one fracture).” c. No other high risk, high volume, or problem‑prone areas were identified. During an interview with the Admin/DPCS on June 2, 2026, from 12:13 PM to 2 PM, the Admin/DPCS stated she was responsible for the QAPI Program. Regarding the Infection Prevention and Control Program, the Admin/DPCS stated she had attempted to pull patient infection information from the agency’s Electronic Medical Record (EMR — a digital version of a patient’s paper chart) system; however, the system continued to indicate zero infections. The Admin/DPCS stated she had been aware of this issue since the 2024 Infection Control Program review but had not addressed it and continued to report zero patient infections for the 2024 through 2026 review period. Regarding the Fall Prevention Program, the Admin/DPCS confirmed her report of two patient falls in 2024, zero patient falls in 2025, and three patient falls (one fracture) in 2026 to date. However, the Admin/DPCS stated she was unable to provide data or the measurement and analysis of that data for the Fall Prevention Program for the 2024 through 2026 time period reviewed. Regarding other high risk, high volume, or problem‑prone areas, the Admin/DPCS stated she was unable to provide additional quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) the QAPI committee had selected to monitor and measure. A review of the agency’s policy and procedure (P&P) titled, “Improving Organizational Performance,” dated November 2023, indicated: “PURPOSE: To establish patient outcomes as the primary focus of the organization's performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem‑prone areas. … PROCEDURE: 1. Senior management with Governing Body oversight will: … C. Focus on high risk, high volume, and problem‑prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. … 1. At least one important aspect related to care must be monitored through use of OASIS data [Outcome and Assessment Information Set — a standardized, federally mandated data set used by the Centers for Medicare & Medicaid Services (CMS) to evaluate a patient's health, plan their treatment, measure the quality of care provided, and determine agency reimbursements]. 2. At least one important administrative aspect of function or service care must be monitored. 3. Monitor indicators related to improved outcomes including the use of emergent care services, hospital admissions and readmissions, and take actions that address performance across the spectrum of care, including the prevention and reduction of medical errors. …”

Program activities CFR(s): 484.65(c) (1) The HHA's performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to conduct QAPI (a system wide improvements with standard setting to elevate patient safety and care quality) program activities required to identify, analyze, and improve high‑risk, high‑volume, and problem‑prone areas from January 2024 through June 4, 2026, for Patients 1 to 132, when it did not ensure accurate infection data, did not measure or analyze fall data, and focused its QAPI efforts primarily on reducing rehospitalizations without tracking or trending whether those rates decreased, remained the same, or increased. The agency also failed to identify or monitor other high‑risk, high‑volume, or problem‑prone areas needed to assess performance across the spectrum of care. These failures had the potential to limit the agency’s ability to identify and implement performance improvement activities that could prevent or reduce patient infections, falls, rehospitalizations, and other adverse events for Patients 1 to 132. Findings: During a review of the QAPI Program on June 2, 2026, the Administrator/Director of Patient Care Services (Admin/DPCS) provided the annual QAPI committee minutes dated January 10, 2025, for the 2024 QAPI Program; the annual QAPI committee minutes dated January 9, 2026, for the 2025 QAPI Program; and the annual QAPI committee minutes dated May 29, 2026, for the 2026 QAPI Program to date. 1. A review of the QAPI committee minutes dated January 10, 2025, indicated: a. “Infection Control Program. Findings reviewed: Zero patient infections. Zero healthcare associated infections. Zero employee exposure incidents. Zero communicable disease outbreaks. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” b. “Fall Prevention Program. Findings reviewed: Two reported patient falls. No major injuries. No fractures. No fall related deaths. No repeat fallers. Committee Determination: The Fall Prevention Program remains effective with continued monitoring recommended.” c. “Hospitalization Program. Findings reviewed: Hospitalizations primarily related to: Falls and injuries. Respiratory conditions. Weakness and deconditioning. Cardiac symptoms. Infections. Disease progression Committee Determination: Hospitalizations were generally clinically appropriate and medically necessary.” d. No other high risk, high volume, or problem prone areas were identified. 2. A review of the QAPI committee minutes dated January 9, 2026, indicated: a. “Infection Prevention and Control Program. Findings reviewed: Zero patient infections. Zero healthcare associated infections. Zero employee exposure events. Zero communicable disease outbreaks. Zero infection related hospitalizations. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” b. “Fall Prevention and Incident Management Program. Findings reviewed: Zero reported falls. Zero fall related injuries. Zero fractures. Zero fall related hospitalizations. Zero repeat fallers. Committee Determination: The Fall Prevention Program was determined to be highly effective.” c. “Hospitalization Reduction Program. Findings reviewed: Hospitalizations primarily involved: Falls and fractures. Respiratory conditions. Pneumonia. Cardiac symptoms. Weakness and deconditioning. Renal complications. Hyperglycemia. Disease progression Committee Determination: Hospitalizations reviewed were generally clinically appropriate and medically necessary.” d. No other high risk, high volume, or problem prone areas were identified. 3. A review of the QAPI committee minutes dated May 29, 2026, indicated: a. “Infection Prevention and Control Program … Findings: Zero infections.” b. “Fall Prevention Program … Findings: … Three falls (one fracture).” c. “Hospitalizations reviewed and generally medically necessary.” d. No other high risk, high volume, or problem prone areas were identified. During an interview on June 2, 2026, from 12:13 PM to 2 PM, the Admin/DPCS stated she was responsible for the QAPI Program. Regarding the Infection Prevention and Control Program, the Admin/DPCS stated she had attempted to pull patient infection data from the agency’s Electronic Medical Record (EMR — a digital version of a patient’s paper chart) system; however, the system continued to indicate zero infections. She stated she had been aware of this issue since the 2024 Infection Control Program review but had not addressed it and continued to report zero patient infections for the 2024 through 2026 review period. The Admin/DPCS stated she could not provide documented evidence showing actions taken to reduce or prevent patient infections, nor any measurement or tracking of these actions to determine whether patient infection rates decreased. She also stated she could not demonstrate that the agency improved patient infection rates. Regarding the Fall Prevention Program, the Admin/DPCS confirmed her report of two patient falls in 2024, zero patient falls in 2025, and three patient falls (one fracture) in 2026 to date. She stated she was unable to provide the data or the measurement and analysis of that data for the Fall Prevention Program for the 2024 through 2026 time period reviewed. The Admin/DPCS stated she could not provide documented evidence showing actions taken to reduce or prevent patient falls, nor any measurement or tracking of these actions to determine whether patient fall rates decreased. She also stated she could not demonstrate that the agency improved patient fall rates. Regarding the Hospitalization Program, the Admin/DPCS stated her report for the Hospitalization Program did not indicate a benchmark (benchmarking is the process of measuring the agency’s performance metrics against recognized standards of care, best practices, or data from peer organizations. It provides a baseline to set realistic quality goals, identify gaps in care, and track sustainable improvements) rehospitalization rate for the agency’s patient population or whether the rehospitalization rate had been reduced, remained the same, or increased during the 2024 through 2026 time period reviewed. She stated she could not provide documented evidence showing actions taken to reduce or prevent patient rehospitalizations, nor any measurement or tracking of these actions to determine whether patient rehospitalization rates decreased, remained the same, or increased. She stated she could not demonstrate that the agency improved/reduced patient rehospitalization rates. Regarding other high risk, high volume, or problem prone areas, the Admin/DPCS stated she was unable to provide additional quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) the QAPI committee had selected to monitor and measure. She stated she could not provide documented evidence that the agency improved its performance in any other high risk, high volume, or problem prone areas. A review of the agency’s policy and procedure (P&P) titled, “Improving Organizational Performance,” dated November 2023, indicated: “PURPOSE: To establish patient outcomes as the primary focus of the organization's performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem prone areas. POLICY: Senior management as designated by the Governing Body will have the responsibility of quality management: to guide the organization’s efforts in improving organizational performance; to define expectations of the performance improvement activities; and to generate the plan and processes the organization will utilize to assess, improve and maintain quality of care and service including appropriateness and effectiveness of patient services. Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications. … PROCEDURE: 1. Senior management with Governing Body oversight will: … C. Focus on high risk, high volume, and problem prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. … E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings. … F. Identify and participate in benchmarking activities that utilize: 1. Internal standards: a. Measuring current performance against past performance. b. Measuring against internally established goals. 2. Processes and protocols. 3. Practice or service guidelines. 4. Industry research or best practices. …”

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP – a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP, and measurable goals to show progress achieved, from January 2024 to June 4, 2026, for Patients 1 to 132. This failure had the potential to cause the agency to overlook problems in care, delay needed corrective actions, and limit efforts to improve the quality and safety of services provided for Patients 1 to 132. Findings: During a review of the QAPI Program (a system wide improvements with standard setting to elevate patient safety and care quality) on June 2, 2026, the Administrator/Director of Patient Care Services (Admin/DPCS) provided the annual QAPI committee minutes dated January 10, 2025, for the 2024 QAPI Program; the annual QAPI committee minutes dated January 9, 2026, for the 2025 QAPI Program; and the annual QAPI committee minutes dated May 29, 2026, for the 2026 QAPI Program to date. 1. A review of the QAPI committee minutes dated January 10, 2025, indicated, “2025 Performance Improvement Projects Approved. The following Performance Improvement Projects (PIPs) were approved for implementation during calendar year 2025:” a. “PIP [number one] Reducing Avoidable Hospitalizations Through Early Intervention and Enhanced Care Coordination.” There was no documented evidence to show that the PIP had been completed in the prior year. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. There was no documented evidence to show any improvement had been sustained. b. “PIP [number two] Reducing Patient Falls Through Enhanced Risk Assessment and Caregiver Education.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. c. “PIP [number three] Enhancing Infection Prevention Through Surveillance and Hand Hygiene Compliance.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. d. “PIP [number four] Maintaining High Patient Satisfaction Through Enhanced Communication and Patient Engagement.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. e. “PIP [number five] Emergency Preparedness Readiness and Continuity of Care Improvement Initiative.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. 2.A review of the QAPI committee minutes dated January 9, 2026, indicated, “2026 Performance Improvement Projects Approved. The following Performance Improvement Projects (PIPs) were approved for implementation during calendar year 2026:” a. “PIP [number one] Reducing Avoidable Hospitalizations Through Enhanced Early Intervention, Fall Prevention, and Chronic Disease Monitoring.” There was no documented evidence to show that the PIP had been completed in the prior year. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. There was no documented evidence to show any improvement had been sustained. b. “PIP [number two] Maintaining Zero Infection Events Through Enhanced Surveillance and Respiratory Illness Prevention.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. c. “PIP [number three] Enhancing Patient Satisfaction Through Patient-Centered Communication and Service Excellence.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. d. “PIP [number four] Maintaining Zero Falls Through Enhanced Risk Assessment and Caregiver Education.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. e. “PIP [number five] Emergency Preparedness Readiness and Continuity of Care Improvement Initiative.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. 3. A review of the QAPI committee minutes dated May 29, 2026, indicated, “Active PIPs remain relevant.” There was no documented evidence to show that the PIPs were currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIPs or data indicating they had problems in the areas targeted for improvements. There was no documented evidence to show the PIPs resulted in improvements, remained the same, or continued to decline. During an interview on June 2, 2026, from 12:13 PM to 2 PM, the Admin/DPCS stated she was responsible for the QAPI Program. Regarding PIP number one, the Admin/DPCS stated she could not show a benchmark (benchmarking is the process of measuring the agency’s performance metrics against recognized standards of care, best practices, or data from peer organizations. It provides a baseline to set realistic quality goals, identify gaps in care, and track sustainable improvements) for the agency’s rehospitalization rate. The Admin/DPCS stated she could not show the interventions applied to reduce the patient rehospitalization rate, or whether the rate had been reduced, remained the same, or declined during the 2024 to 2026 review period. The Admin/DPCS stated she was unable to show any improvements, or if improvements had occurred, that the improvements had been sustained. Regarding PIPs numbered two through five, the Admin/DPCS stated she did not have documented evidence to show that the PIPs were currently underway or completed in the prior year. The Admin/DPCS stated she did not have documented evidence to show rationales for undertaking the PIPs or data indicating the agency had a problem in the areas targeted for improvement. The Admin/DPCS stated she did not have documented evidence to show the PIPs resulted in improvements, remained the same, or continued to decline. A review of the agency’s policy and procedure (P&P) titled, “Improving Organizational Performance,” dated November 2023, indicated: “PURPOSE: To establish patient outcomes as the primary focus of the organization’s performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem prone areas. … PROCEDURE: … H. Ensure that performance improvement projects are conducted that reflect the following standards: 1. The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the organization’s services and operations. 2. The organization must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. …”

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on interview and record review, the agency’s Governing Body (GB-a group of individuals vested with the ultimate authority, power, and responsibility to guide an organization, guide policy, and make binding decisions) failed to ensure that an ongoing Quality Assessment and Performance Improvement (QAPI) Program addressed priorities for improved quality of care and patient safety, and the GB failed to evaluate all improvement actions for effectiveness from January 2024 through June 4, 2026, for Patients 1 through 132, when: 1. The agency failed to measure, analyze, and track quality indicators to assess processes of care, agency services, and operations from January 2024 to June 4, 2026, for Patients 1 to 132. Although the agency reported reviewing infections and falls, the agency did not ensure the accuracy of infection data, did not measure or analyze fall data, and did not identify or monitor other high risk, high volume, or problem‑prone areas as required. This failure had the potential to cause delays in identifying and addressing patient infections, patient falls, and other high risk, high volume, or problem‑prone areas because the agency did not measure, analyze, or track these indicators within its quality assessment and performance improvement processes. 2. The agency failed to conduct QAPI program activities required to identify, analyze, and improve high‑risk, high‑volume, and problem‑prone areas from January 2024 through June 4, 2026, for Patients 1 to 132, when it did not ensure accurate infection data, did not measure or analyze fall data, and focused its QAPI efforts primarily on reducing rehospitalizations without tracking or trending whether those rates decreased, remained the same, or increased. The agency also failed to identify or monitor other high‑risk, high‑volume, or problem‑prone areas needed to assess performance across the spectrum of care. These failures had the potential to limit the agency’s ability to identify and implement performance improvement activities that could prevent or reduce patient infections, falls, rehospitalizations, and other adverse events for Patients 1 to 132. 3. The agency failed to conduct and document performance improvement projects (PIP – a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP, and measurable goals to show progress achieved, from January 2024 to June 4, 2026, for Patients 1 to 132. This failure had the potential to cause the agency to overlook problems in care, delay needed corrective actions, and limit efforts to improve the quality and safety of services provided to patients. Findings: 1. During a review of the Quality Assessment and Performance Improvement (QAPI) Program on June 2, 2026, the Administrator/Director of Patient Care Services (Admin/DPCS) provided the annual QAPI committee minutes dated January 10, 2025, for the review of the 2024 QAPI Program; the annual QAPI committee minutes dated January 9, 2026, for the review of the 2025 QAPI Program; and the annual QAPI committee minutes dated May 29, 2026, for the review of the 2026 QAPI Program to date. a. A review of the QAPI committee minutes dated January 10, 2025, indicated: i. “Infection Control Program. Findings reviewed: Zero patient infections. Zero healthcare‑associated infections. Zero employee exposure incidents. Zero communicable disease outbreaks. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” ii. “Fall Prevention Program. Findings reviewed: Two reported patient falls. No major injuries. No fractures. No fall‑related deaths. No repeat fallers. Committee Determination: The Fall Prevention Program remains effective with continued monitoring recommended.” iii. No other high risk, high volume, or problem‑prone areas were identified. b. A review of the QAPI committee minutes dated January 9, 2026, indicated: i. “Infection Prevention and Control Program. Findings reviewed: Zero patient infections. Zero healthcare‑associated infections. Zero employee exposure events. Zero communicable disease outbreaks. Zero infection‑related hospitalizations. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” ii. “Fall Prevention and Incident Management Program. Findings reviewed: Zero reported falls. Zero fall‑related injuries. Zero fractures. Zero fall‑related hospitalizations. Zero repeat fallers. Committee Determination: The Fall Prevention Program was determined to be highly effective.” iii. No other high risk, high volume, or problem‑prone areas were identified. c. A review of the QAPI committee minutes dated May 29, 2026, indicated: i. “Infection Prevention and Control Program … Findings: Zero infections.” ii. “Fall Prevention Program … Findings: … Three falls (one fracture).” iii. No other high risk, high volume, or problem‑prone areas were identified. During an interview with the Admin/DPCS on June 2, 2026, from 12:13 PM to 2 PM, the Admin/DPCS stated she was responsible for the QAPI Program. Regarding the Infection Prevention and Control Program, the Admin/DPCS stated she had attempted to pull patient infection information from the agency’s Electronic Medical Record (EMR — a digital version of a patient’s paper chart) system; however, the system continued to indicate zero infections. The Admin/DPCS stated she had been aware of this issue since the 2024 Infection Control Program review but had not addressed it and continued to report zero patient infections for the 2024 through 2026 review period. Regarding the Fall Prevention Program, the Admin/DPCS confirmed her report of two patient falls in 2024, zero patient falls in 2025, and three patient falls (one fracture) in 2026 to date. However, the Admin/DPCS stated she was unable to provide data or the measurement and analysis of that data for the Fall Prevention Program for the 2024 through 2026 time period reviewed. Regarding other high risk, high volume, or problem‑prone areas, the Admin/DPCS stated she was unable to provide additional quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) the QAPI committee had selected to monitor and measure. A review of the agency’s policy and procedure (P&P) titled, “Improving Organizational Performance,” dated November 2023, indicated: “PURPOSE: To establish patient outcomes as the primary focus of the organization's performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem‑prone areas. … PROCEDURE: 1. Senior management with Governing Body oversight will: … C. Focus on high risk, high volume, and problem‑prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. … 1. At least one important aspect related to care must be monitored through use of OASIS data [Outcome and Assessment Information Set — a standardized, federally mandated data set used by the Centers for Medicare & Medicaid Services (CMS) to evaluate a patient's health, plan their treatment, measure the quality of care provided, and determine agency reimbursements]. 2. At least one important administrative aspect of function or service care must be monitored. 3. Monitor indicators related to improved outcomes including the use of emergent care services, hospital admissions and readmissions, and take actions that address performance across the spectrum of care, including the prevention and reduction of medical errors. …” 2. During a review of the QAPI Program on June 2, 2026, the Administrator/Director of Patient Care Services (Admin/DPCS) provided the annual QAPI committee minutes dated January 10, 2025, for the 2024 QAPI Program; the annual QAPI committee minutes dated January 9, 2026, for the 2025 QAPI Program; and the annual QAPI committee minutes dated May 29, 2026, for the 2026 QAPI Program to date. a. A review of the QAPI committee minutes dated January 10, 2025, indicated: i. “Infection Control Program. Findings reviewed: Zero patient infections. Zero healthcare associated infections. Zero employee exposure incidents. Zero communicable disease outbreaks. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” ii. “Fall Prevention Program. Findings reviewed: Two reported patient falls. No major injuries. No fractures. No fall related deaths. No repeat fallers. Committee Determination: The Fall Prevention Program remains effective with continued monitoring recommended.” iii. “Hospitalization Program. Findings reviewed: Hospitalizations primarily related to: Falls and injuries. Respiratory conditions. Weakness and deconditioning. Cardiac symptoms. Infections. Disease progression Committee Determination: Hospitalizations were generally clinically appropriate and medically necessary.” iv. No other high risk, high volume, or problem prone areas were identified. b. A review of the QAPI committee minutes dated January 9, 2026, indicated: i. “Infection Prevention and Control Program. Findings reviewed: Zero patient infections. Zero healthcare associated infections. Zero employee exposure events. Zero communicable disease outbreaks. Zero infection related hospitalizations. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” ii. “Fall Prevention and Incident Management Program. Findings reviewed: Zero reported falls. Zero fall related injuries. Zero fractures. Zero fall related hospitalizations. Zero repeat fallers. Committee Determination: The Fall Prevention Program was determined to be highly effective.” iii. “Hospitalization Reduction Program. Findings reviewed: Hospitalizations primarily involved: Falls and fractures. Respiratory conditions. Pneumonia. Cardiac symptoms. Weakness and deconditioning. Renal complications. Hyperglycemia. Disease progression Committee Determination: Hospitalizations reviewed were generally clinically appropriate and medically necessary.” iv. No other high risk, high volume, or problem prone areas were identified. c. A review of the QAPI committee minutes dated May 29, 2026, indicated: i. “Infection Prevention and Control Program … Findings: Zero infections.” ii. “Fall Prevention Program … Findings: … Three falls (one fracture).” iii. “Hospitalizations reviewed and generally medically necessary.” iv. No other high risk, high volume, or problem prone areas were identified. During an interview on June 2, 2026, from 12:13 PM to 2 PM, the Admin/DPCS stated she was responsible for the QAPI Program. Regarding the Infection Prevention and Control Program, the Admin/DPCS stated she had attempted to pull patient infection data from the agency’s Electronic Medical Record (EMR — a digital version of a patient’s paper chart) system; however, the system continued to indicate zero infections. She stated she had been aware of this issue since the 2024 Infection Control Program review but had not addressed it and continued to report zero patient infections for the 2024 through 2026 review period. The Admin/DPCS stated she could not provide documented evidence showing actions taken to reduce or prevent patient infections, nor any measurement or tracking of these actions to determine whether patient infection rates decreased. She also stated she could not demonstrate that the agency improved patient infection rates. Regarding the Fall Prevention Program, the Admin/DPCS confirmed her report of two patient falls in 2024, zero patient falls in 2025, and three patient falls (one fracture) in 2026 to date. She stated she was unable to provide the data or the measurement and analysis of that data for the Fall Prevention Program for the 2024 through 2026 time period reviewed. The Admin/DPCS stated she could not provide documented evidence showing actions taken to reduce or prevent patient falls, nor any measurement or tracking of these actions to determine whether patient fall rates decreased. She also stated she could not demonstrate that the agency improved patient fall rates. Regarding the Hospitalization Program, the Admin/DPCS stated her report for the Hospitalization Program did not indicate a benchmark (benchmarking is the process of measuring the agency’s performance metrics against recognized standards of care, best practices, or data from peer organizations. It provides a baseline to set realistic quality goals, identify gaps in care, and track sustainable improvements) rehospitalization rate for the agency’s patient population or whether the rehospitalization rate had been reduced, remained the same, or increased during the 2024 through 2026 time period reviewed. She stated she could not provide documented evidence showing actions taken to reduce or prevent patient rehospitalizations, nor any measurement or tracking of these actions to determine whether patient rehospitalization rates decreased, remained the same, or increased. She stated she could not demonstrate that the agency improved/reduced patient rehospitalization rates. Regarding other high risk, high volume, or problem prone areas, the Admin/DPCS stated she was unable to provide additional quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) the QAPI committee had selected to monitor and measure. She stated she could not provide documented evidence that the agency improved its performance in any other high risk, high volume, or problem prone areas. A review of the agency’s policy and procedure (P&P) titled, “Improving Organizational Performance,” dated November 2023, indicated: “PURPOSE: To establish patient outcomes as the primary focus of the organization's performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem prone areas. POLICY: Senior management as designated by the Governing Body will have the responsibility of quality management: to guide the organization’s efforts in improving organizational performance; to define expectations of the performance improvement activities; and to generate the plan and processes the organization will utilize to assess, improve and maintain quality of care and service including appropriateness and effectiveness of patient services. Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications. … PROCEDURE: 1. Senior management with Governing Body oversight will: … C. Focus on high risk, high volume, and problem prone areas. Consider incidence, prevalence, and severity of problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. … E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings. … F. Identify and participate in benchmarking activities that utilize: 1. Internal standards: a. Measuring current performance against past performance. b. Measuring against internally established goals. 2. Processes and protocols. 3. Practice or service guidelines. 4. Industry research or best practices. …” c. During a review of the QAPI Program on June 2, 2026, the Administrator/Director of Patient Care Services (Admin/DPCS) provided the annual QAPI committee minutes dated January 10, 2025, for the 2024 QAPI Program; the annual QAPI committee minutes dated January 9, 2026, for the 2025 QAPI Program; and the annual QAPI committee minutes dated May 29, 2026, for the 2026 QAPI Program to date. I. A review of the QAPI committee minutes dated January 10, 2025, indicated, “2025 Performance Improvement Projects Approved. The following Performance Improvement Projects (PIPs) were approved for implementation during calendar year 2025:” i. “PIP [number one] Reducing Avoidable Hospitalizations Through Early Intervention and Enhanced Care Coordination.” There was no documented evidence to show that the PIP had been completed in the prior year. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. There was no documented evidence to show any improvement had been sustained. ii. “PIP [number two] Reducing Patient Falls Through Enhanced Risk Assessment and Caregiver Education.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. iii. “PIP [number three] Enhancing Infection Prevention Through Surveillance and Hand Hygiene Compliance.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. iv. “PIP [number four] Maintaining High Patient Satisfaction Through Enhanced Communication and Patient Engagement.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. v. “PIP [number five] Emergency Preparedness Readiness and Continuity of Care Improvement Initiative.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. II.A review of the QAPI committee minutes dated January 9, 2026, indicated, “2026 Performance Improvement Projects Approved. The following Performance Improvement Projects (PIPs) were approved for implementation during calendar year 2026:” i. “PIP [number one] Reducing Avoidable Hospitalizations Through Enhanced Early Intervention, Fall Prevention, and Chronic Disease Monitoring.” There was no documented evidence to show that the PIP had been completed in the prior year. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. There was no documented evidence to show any improvement had been sustained. ii. “PIP [number two] Maintaining Zero Infection Events Through Enhanced Surveillance and Respiratory Illness Prevention.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. iii. “PIP [number three] Enhancing Patient Satisfaction Through Patient-Centered Communication and Service Excellence.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. iv. “PIP [number four] Maintaining Zero Falls Through Enhanced Risk Assessment and Caregiver Education.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. v. “PIP [number five] Emergency Preparedness Readiness and Continuity of Care Improvement Initiative.” There was no documented evidence to show that the PIP was currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIP or data indicating it had a problem in the area targeted for improvement. There was no documented evidence to show the PIP resulted in an improvement, remained the same, or continued to decline. III. A review of the QAPI committee minutes dated May 29, 2026, indicated, “Active PIPs remain relevant.” There was no documented evidence to show that the PIPs were currently underway or completed in the prior year. There was no documented evidence to show a rationale for undertaking the PIPs or data indicating they had problems in the areas targeted for improvements. There was no documented evidence to show the PIPs resulted in improvements, remained the same, or continued to decline. During an interview on June 2, 2026, from 12:13 PM to 2 PM, the Admin/DPCS stated she was responsible for the QAPI Program. Regarding PIP number one, the Admin/DPCS stated she could not show a benchmark (benchmarking is the process of measuring the agency’s performance metrics against recognized standards of care, best practices, or data from peer organizations. It provides a baseline to set realistic quality goals, identify gaps in care, and track sustainable improvements) for the agency’s rehospitalization rate. The Admin/DPCS stated she could not show the interventions applied to reduce the patient rehospitalization rate, or whether the rate had been reduced, remained the same, or declined during the 2024 to 2026 review period. The Admin/DPCS stated she was unable to show any improvements, or if improvements had occurred, that the improvements had been sustained. Regarding PIPs numbered two through five, the Admin/DPCS stated she did not have documented evidence to show that the PIPs were currently underway or completed in the prior year. The Admin/DPCS stated she did not have documented evidence to show rationales for undertaking the PIPs or data indicating the agency had a problem in the areas targeted for improvement. The Admin/DPCS stated she did not have documented evidence to show the PIPs resulted in improvements, remained the same, or continued to decline. A review of the agency’s policy and procedure titled “Improving Organizational Performance,” dated November 2023, indicated: “PURPOSE: To establish patient outcomes as the primary focus of the organization’s performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem prone areas. … PROCEDURE: … H. Ensure that performance improvement projects are conducted that reflect the following standards: 1. The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the organization’s services and operations. 2. The organization must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. …” During an interview with the Admin/DPCS and the Owner/AD on June 2, 2026, at 2 PM, the Owner/AD and the Admin/DPCS stated they were members of the Governing Body (GB) and had assumed responsibility for ensuring the QAPI Program addressed priorities for improved quality of care and patient safety, and that all improvement actions were evaluated for effectiveness. Regarding the Infection Prevention and Control Program, the Admin/DPCS stated she knew the zero patient infection rates reported to the GB for the 2024 through 2026 review period were inaccurate but had made no attempt to correct them. The Owner/AD stated he had not questioned a zero patient infection rate for the 2024 through 2026 review period. Regarding the Fall Prevention Program, the Admin/DPCS confirmed she had not reported to the GB the actions taken to reduce or prevent patient falls, nor the measurements or tracking needed to determine whether patient fall rates had decreased or improved. The Owner/AD stated he had not questioned the absence of actions to reduce or prevent patient falls, the lack of measurements or tracking to determine whether patient fall rates had decreased, or whether there had been any improvement in patient fall rates for the 2024 through 2026 review period. Regarding the Hospitalization Program, the Admin/DPCS confirmed she had not determined or reported to the GB a benchmark rehospitalization rate for the agency’s patient population, nor whether the rehospitalization rate had been reduced, remained the same, or increased during the 2024 through 2026 review period. The Owner/AD stated he had not questioned the lack of information on the progress of the Hospitalization Program for the 2024 through 2026 review period. Regarding other high‑risk, high‑volume, or problem‑prone areas, the Admin/DPCS confirmed she had not reported to the GB any additional quality indicators the QAPI committee was monitoring and measuring for the 2024 through 2026 review period. The Owner/AD stated he had not asked about any additional areas the QAPI Program was monitoring during the 2024 through 2026 review period. Regarding PIPs numbered one through five, the Admin/DPCS confirmed she had not reported to the GB the progress of PIPs one through five or whether the PIPs resulted in improvements, remained the same, or continued to decline. The Owner/AD stated he had not asked about the progress of the PIPs. A review of the agency’s policy and procedure (P&P) titled, “Improving Organizational Performance,” dated November 2023, indicated: “PURPOSE: To establish patient outcomes as the primary focus of the organization's performance improvement activities. To improve organizational performance by focusing on high risk, high volume, and problem prone areas. POLICY: … The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually.”

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: The agency failed to ensure the Condition of Participation: G 680 §484.70 Condition of Participation, Infection Prevention and Control, was in compliance when: 1. Based on observation, interview, and record review, the agency failed to ensure standard precautions (the minimum infection prevention and control practices used for the care of all patients at all times) were followed to prevent the transmission of infections and communicable diseases for seven of seven sampled patients (Patients 1, 2, 3, 4, 5, 6, and 7) when: a. A Physical Therapist (PT) did not perform hand hygiene (the primary defense against the spread of germs and infections which includes washing hands with soap and water or using alcohol based hand sanitizer) or use clean bag technique (a systematic procedure for carrying, organizing, and using medical supplies to protect the home health bag from becoming contaminated and to prevent the spread of pathogens between patients and environments) while providing care for Patient 3. (Refer G 682) b. Stored medical supplies had passed their expiration date and were available for use for sampled patients 1, 2, 3, 4, 5, 6, and 7. (Refer G 682) 2. Based on interview and record review, the agency failed to maintain a coordinated, agency‑wide program for the surveillance, identification, prevention, control, and investigation of infections that was integrated into the agency’s Quality Assessment Performance Improvement (QAPI) program ( a system wide improvements with standards setting to elevate patient safety and care quality) when, from January 2024 to June 4, 2026, the agency did not collect patient infection data, identify infection trends, develop action plans, or improve disease prevention for Patients 1 through 132. (Refer to G 684) The cumulative effect of these systemic practices had the potential to place patients at risk for infection because staff did not follow standard precautions, expired supplies were available for patient care, and the agency did not collect, review, or act on infection data for all patients served.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure standard precautions (the minimum infection prevention and control practices used for the care of all patients at all times) were followed to prevent the transmission of infections and communicable diseases for seven (7) of seven (7) sampled patients (Patients 1, 2,3,4,5, 6, and 7) when: 1.A Physical Therapist (PT) did not perform hand hygiene (primary defense against the spread of germs and infections which includes washing with soap and water or using alcohol based hand sanitizer) or used clean bag technique (an infection control standard used in home health care to keep medical supplies organized and prevent the cross contamination of germs between patients, the environment, and staff) while providing care for Patient 3. 2.Stored medical supplies were expired and available for use for Patients 1, 2, 3, 4, 5, 6, and 7. This failure had the potential to put the agency’s patients at risk for cross contamination (the process by which bacteria or other microorganism are unintentionally transferred from one substance or object to another) of infectious microorganisms. Findings: A review of Patient 3’s face sheet (contains demographic and medical information), undated, indicated Patient 3 had a start of care date of April 1, 2026, with a certification period of April 1, 2026, to May 30, 2026. Patient 3 had diagnoses which included obstructive and reflux uropathy (a condition where a urinary tract blockage forces urine to flow backwards into the kidneys), and urinary tract infection (a bacterial infection in the urinary system (kidneys, ureters, bladder, and urethra). 1.During a home visit observation on June 2, 2026, at 4:15 PM, with Physical Therapist (PT), and in the presence of Patient 3, PT did not perform hand hygiene before and after giving care to Patient 3 and did not follow the clean bag technique to prevent cross examination. PT placed his bag on the floor, and on Patient 3's bed without the use of protective barrier for bag placement. PT did not wash his hands with soap and water or use any alcohol-based hand rub prior to giving and post care to Patient 3. During an interview on June 2, 2026 at 4:55 PM, PT stated he should have performed hand hygiene by washing his hands before giving care to Patient 3, with soap and water or alcohol rub and should have used barrier/paper towel for putting his bag on floor or table to prevent cross contamination, he forgot to do that, he was focused on the patient and the task he was performing. During an interview on June 3, 2026, at 10:00 AM, with Director of Patient Care Services (DPCS), DPCS stated staff were supposed to do hand hygiene before and after giving care to patients and were supposed to use a barrier to put the bag and belongings and/or equipment on when in the patient’s home. The DPCS further started PT should have washed/ used alcohol rub to perform hand hygiene and should have not placed the bag on the floor without using protective barrier to prevent cross examination. During a review of the agency’s policy and procedure (P&P) titled, “STANDARD PRECAUTIONS”, dated November 2023, the P&P indicated, “PURPOSE-To reduce the risk of exposure of infections when caring for patients…PROCEDURE-General Precautions- Hand Hygiene 1. Hand hygiene will be performed to prevent cross-contamination between the patients and personnel." During a review of the agency's P&P titled, “BAG TECHNIQUE”, dared November 2023, the policy indicated, “PURPOSE- To describe the procedure for maintaining a clean nursing bag/computer bag and preventing cross-contamination…PROCEDURE-Bag Technique-1. The bag will be placed on a clean surface (i.e. a surface that can be easily disinfected) in the car and in the home…5. When a visit is completed, reusable equipment will be cleaned using alcohol, soap and water, or other appropriate solutions, hands will be washed, and equipment and supplies will be returned to the bag…7. If paper towels/newspapers have been used as protective barrier for bag placement in the Patients home, they will be discarded." 2.During a concurrent observation and interview with the licensed vocational nurse/Intake coordinator (IC), on June 3, 2026, at 10:00 AM, in the conference room/medical supplies room, the following medical supplies were found to be expired and were available to use: One (1) tube of [Brand] of Menthol and Zinc Ointment (a skin protectant used to relieve itching, pain, and burning while forming a waterproof barrier against moisture, sweat, urine, and stool) with an expiration date of July 2025 (expired for 307 days). One (1) box of 50 [Brand] of short needle insulin (a hormone that regulates the amount of sugar in the blood) syringes (a device designed to minimize injection pain and the risk of injecting into muscle rather than fat) with an expiration date of May 31, 2026 (expired for 3 days). The IC verified that all the medical supplies were expired and should have been discarded. A review of the agency’s policy and procedure (P&P) titled, “SAFE AND APPROPRIATE USE OF MEDICAL EQUIPMENT AND SUPPLIES”, dated November 2023, indicated, “PURPOSE-All home medical equipment and medical supplies will be managed in a safe and appropriate manner…." A review of the agency's P&P titled, “STORAGE OF MEDICATIONS AND NUTRITIONAL THERAPIES”, dated November 2023, indicated, “PROCEDURE-4. All medications, chemicals, and biologicals will be labelled for contents, with expiration dates clearly identified”. During an interview on June 3, 2026 at 1:15 PM, the ADMIN/DPCS stated the medical supplies should have been checked regularly and expired items should have been discarded. The ADMIN/DPCS further stated the agency did not follow their P&P.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to maintain a coordinated, agency‑wide program for the surveillance, identification, prevention, control, and investigation of infections that was integrated into the agency’s Quality Assessment Performance Improvement (QAPI) program (a system-wide improvements with standard setting to improve patient safety and care quality) when, from January 2024 to June 4, 2026, the agency did not collect patient infection data, identify infection trends, develop action plans, or improve disease prevention for Patients 1 through 132. This failure had the potential to cause infection trends to go unrecognized and prevent the agency from analyzing possible causes of increases in infections, which could lead to delays in implementing actions needed to protect the health for Patients 1 through 132. Findings: During a review of the Infection Control Program on June 2, 2026, the Administrator/Director of Patient Care Services (Admin/DPCS) provided the annual QAPI committee minutes dated January 10, 2025, for the review of the 2024 Infection Control Program; the annual QAPI committee minutes dated January 9, 2026, for the review of the 2025 Infection Control Program; and the annual QAPI committee minutes dated May 29, 2026, for the review of the 2026 Infection Control Program to date. A review of the QAPI committee minutes dated January 10, 2025, indicated, “The QAPI Committee reviewed agency performance data collected from January 1, 2024, through December 31, 2024. Infection Control Program. Findings reviewed: Zero patient infections. Zero healthcare-associated infections. Zero employee exposure incidents. Zero communicable disease outbreaks. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” A review of the QAPI committee minutes dated January 9, 2026, indicated, “The QAPI Committee reviewed agency performance data collected from January 1, 2025, through December 31, 2025. Infection Prevention and Control Program. Findings reviewed: Zero patient infections. Zero healthcare-associated infections. Zero employee exposure events. Zero communicable disease outbreaks. Zero infection-related hospitalizations Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” A review of the QAPI committee minutes dated May 29, 2026, indicated, “Date: May 29, 2026, Time: 1:00 PM - 2:00 PM. The QAPI Committee reviewed: Infection Prevention and Control Program … Findings: Zero infections. …” During a concurrent record review and interview with the Admin/DPCS on June 2, 2026, at 11:30 AM, the Admin/DPCS stated she was responsible for the Infection Control Program. The Admin/DPCS stated she had tried to pull patient infection information from the agency Electronic Medical Record (EMR — a digital version of a patient's paper chart) system; however, it kept indicating zero infections. The Admin/DPCS stated she had been aware this was a problem since the 2024 Infection Control Program review but had not addressed it and continued to report zero patient infections for the 2024 through 2026 review. The Admin/DPCS reviewed the agency’s policy and procedure (P&P) titled, “Evaluating and Maintaining Records of Infections Among Patients,” dated November 2023, and acknowledged the P&P indicated: “PROCEDURE: The Infection Identification-Patient Report form is completed when any of the following occur: A. A new, actual, or suspected infection is clinically observed by personnel B. A culture is ordered and performed, and the results are positive C. A new antibiotic is ordered D. A patient is admitted to a hospital due to an actual or suspected infection E. An unanticipated death due to an actual or suspected infection F. A major permanent loss of function associated with an actual or suspected infection G. A reportable, communicable infection is identified H. Patient has temperatures greater than 101 degrees F [Fahrenheit — a unit of measurement] I. Patient has conjunctivitis [inflammation or infection of the conjunctiva — the clear, thin membrane that covers the white part of the eyeball and the inside of the eyelids.] The Case Manager or the nurse caring for the patient in his/her absence should complete the Infection Identification Patient Report within 24 hours of discovering the infection. Each section of the report should be completed in its entirety. Note: If patient was admitted to home care from a hospital and a new infection was identified by the clinician within the first 48 hours of service, the source of the suspected infection may be nosocomial [an infection that occurs in the hospital]. After completion, the original form will be sent to the Performance Improvement Coordinator, and a copy will be submitted to the appropriate personnel for follow-up. … [The P&P included a blank “Infection Identification-Patient Report,” for use] …” The Admin/DPCS further stated she had not followed the P&P or utilized the “Infection Identification-Patient Report.” A review of the agency’s Policy and Procedure (P&P) titled, "Infection Control Plan," dated November 2023, indicated, “PURPOSE: To delineate an infection control plan to meet the following goals: 1. Establish the mechanism by which the organization will address surveillance, prevention, identification, control and reporting of infections, utilizing current scientific methods and epidemiologic principles [the study of how, when, and why diseases and health events spread within groups of people]. … 4. Provide for surveillance systems to track the occurrence and transmission of infections. 5. Comply with all applicable local, state, federal regulations, and accepted standards of practice including, but not limited to: … D. Agency for Healthcare Research and Quality (AHRQ). E. Association for Professionals in Infection Control and Epidemiology (APIC). F. Local regulations including reporting of outbreaks or undue prevalence of infections, parasitic disease or infestation. POLICY: [name of agency] is committed to reducing the risk of acquisition and transmission of health care associated infections (HAIs). Recognized prevention and control mechanisms will be implemented for planning, surveillance, identification, prevention/controls, and reporting procedures. To determine the effectiveness of the infection control plan, [name of agency] will measure, assess, improve, and redesign (as appropriate) the surveillance, identification, prevention, and control function annually through its performance improvement program. …”

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to maintain and keep current a Clinical Laboratory Improvement Amendment (CLIA—a federal certification that allows healthcare facilities to legally perform simple, low‑risk diagnostic tests) certificate for 132 patients (Patients 1 through 132) during the three‑year period reviewed, 2024 through 2026. This failure had the potential to result in diagnostic testing being performed without assurance of accuracy or compliance with required laboratory standards, which could lead to delayed identification of health conditions and unmet healthcare needs for Patients 1 through 132). Findings: During a tour of the agency and an interview on June 1, 2026, at 10 AM with an Intake Coordinator (IC), the agency’s postings were reviewed. The IC confirmed there was no posting of a CLIA certificate. During an interview with the Owner/Administrator Designee (Owner/AD) on June 2, 2026, at 9:39 AM, the Owner/AD stated he was responsible for maintaining and keeping the CLIA certificate current. The Owner/AD stated there was no current CLIA certificate and he did not know how long it had been expired. The Owner/AD stated he had attempted to renew the CLIA certificate in 2024, but nothing had come of it, and he had not followed up on its status. A review of the agency’s policy and procedure (P&P) titled, “Waived Testing,” dated November 2023, indicated, “PURPOSE: To define the organization's compliance with waived testing criteria and the need for a certificate of laboratory services. … PROCEDURE: 1. [name of the agency] will perform permitted laboratory tests in the home. 2. [name of the agency] will apply for and maintain a CLIA waiver on file. …”

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: The agency failed to ensure the Condition of Participation: G 940 484.105 Organization and administration of services was in compliance when: Based on interview, and record review, the Governing Body (GB-a group of individuals vested with the ultimate authority, power, and responsibility to guide an organization, guide policy, and make binding decisions) failed to operate and manage the agency from January 2024, to June 4, 2026, for Patients 1 through 132, when: 1. Based on interview and record review, the agency failed to maintain and keep current a Clinical Laboratory Improvement Amendment (CLIA—a federal certification that allows healthcare facilities to legally perform simple, low‑risk diagnostic tests) certificate for 132 patients (Patients 1 through 132) during the three‑year period reviewed, 2024 through 2026. (Refer to G 942) 2. Based on interview and record review, the agency failed to maintain and keep current a California Department of Public Health Laboratory Registration (CDPH Lab. Reg.--a state-issued document that legally permits a healthcare facility to perform simple, low-risk diagnostic testing (such as routine blood glucose (sugar in the blood) or urine dipstick tests [a medical strip dip into a cup of urine to determine the function of the kidneys]on patients) certificate for 132 patients (Patients 1 through 132) during the three‑year period reviewed, 2024 through 2026. (Refer to G 942) 3. Based on observation, interview, and record review, the facility failed to ensure personal health information was kept confidential for one of seven sampled patients (Patient 1) when a Registered Nurse 1 (RN 1) received and sent Patient 1’s clinical records using her personal cell phone. (Refer to G 942) 4. Based on observation, interview, and record review, the agency failed to ensure standard precautions (the minimum infection prevention and control practices used for the care of all patients at all times) were followed to prevent the transmission of infections and communicable diseases for seven sampled patients (Patient 1, 2,3,4,5, 6, and 7) when: a. A Physical Therapist (PT) did not perform hand hygiene or used clean bag technique while providing care for Patient 3. (Refer to G 942) b. Stored medical supplies had passed their expirations date and were available for use for sampled Patients 1, 2, 3, 4, 5, 6, and 7. (Refer to G 942) 5. Based on interview and record review, the agency failed to maintain a coordinated, agency‑wide program for the surveillance, identification, prevention, control, and investigation of infections that was integrated into the agency’s Quality Assessment Performance Improvement (QAPI) program (a system wide improvements with standards setting to elevate patient safety and care quality) when, from January 2024 to June 4, 2026, the agency did not collect patient infection data, identify infection trends, develop action plans, or improve disease prevention for Patients 1 through 132. (Refer to G 942) 6. Based on interview and record review, the agency failed to ensure a physician reviewed and signed the patients' plans of care (an individualized, structured document outlining the medical, supportive, or personal services a patient requires) within 30 working days of the patients' start of care as required by State law and the agency's policy and procedure (P&P) titled, “Physician Participation in Plan of Care,” dated November 2023, for five of seven sampled patients (Patients 1, 2, 3, 6, and 7). (Refer to G 942) 7. Based on interview and record review, the agency failed to ensure the physicians reviewed and signed verbal orders (a directive given by the doctor orally either in person or over the phone) within 30 working days of the date of the order as required by State law and the agency's policy and procedure (P&P) titled, “Verification of Physician Orders,” dated November 2023, for four of seven sampled patients (Patients 2, 3, 6 and 7). (Refer to G 942) The cumulative effect of these systemic practices resulted in the potential for widespread harm, placing all 132 patients at significant risk for delayed or improper care, breaches of protected health information, inadequate infection prevention and control, and the delivery of services without the legally required clinical oversight. These failures demonstrated that the Governing Body did not ensure the safe, lawful, and effective operation of the agency, jeopardizing the health, safety, and rights of every patient served.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on interview, and record review, the Governing Body (GB-a group of individuals vested with the ultimate authority, power, and responsibility to guide an organization, guide policy, and make binding decisions) failed to operate and manage the agency from January 2024, to June 4, 2026, for Patients 1 through 132, when: 1. Based on interview and record review, the agency failed to maintain and keep current a Clinical Laboratory Improvement Amendment (CLIA—a federal certification that allows healthcare facilities to legally perform simple, low‑risk diagnostic tests) certificate for 132 patients (Patients 1 through 132) during the three‑year period reviewed, 2024 through 2026. This failure had the potential to result in diagnostic testing being performed without assurance of accuracy or compliance with required laboratory standards, which could lead to delayed identification of health conditions and unmet healthcare needs. 2. Based on interview and record review, the agency failed to maintain and keep current a California Department of Public Health Laboratory Registration (CDPH Lab. Reg.--a state-issued document that legally permits a healthcare facility to perform simple, low-risk diagnostic testing (such as routine blood glucose (blood sugar) or urine dipstick tests( a strip that is dip in a cup of urine to determine the functions of the kidneys) on patients) certificate for 132 patients (Patients 1 through 132) during the three‑year period reviewed, 2024 through 2026. This failure had the potential to cause diagnostic testing to be performed without assurance of accuracy or compliance with required state laboratory standards, which could result in delayed identification of health conditions and unmet healthcare needs. 3. Based on observation, interview, and record review, the facility failed to ensure personal health information was kept confidential for one of seven sampled patients (Patient 1) when a Registered Nurse 1 (RN 1) received and sent Patient 1’s clinical records using her personal cell phone. This failure resulted in Patient 1’s personal health information being put at risk by not keeping health records confidential, and using personal equipment not being monitored and secured by the agency. 4. Based on observation, interview, and record review, the agency failed to ensure standard precautions (the minimum infection prevention and control practices used for the care of all patients at all times) were followed to prevent the transmission of infections and communicable diseases for seven sampled patients (Patient 1, 2,3,4,5, 6, and 7) when: a. A Physical Therapist (PT) did not perform hand hygiene or used clean bag technique while providing care for Patient 3. b. Stored medical supplies were available for use and had passed their expiration date for sampled Patients 1, 2, 3, 4, 5, 6, and 7. This failure had the potential to put the agency’s Patients 1, 2, 3, 4, 5, 6, and 7 at risk for cross contamination (the process by which bacteria or other microorganism are unintentionally transferred from one substance or object to another). 5. Based on interview and record review, the agency failed to maintain a coordinated, agency‑wide program for the surveillance, identification, prevention, control, and investigation of infections that was integrated into the agency’s Quality Assessment Performance Improvement (QAPI) program (a system wide improvements with standards setting to elevate patient safety and care quality) when, from January 2024 to June 4, 2026, the agency did not collect patient infection data, identify infection trends, develop action plans, or improve disease prevention for Patients 1 through 132. This failure had the potential to cause infection trends to go unrecognized and prevent the agency from analyzing possible causes of increases in infections, which could lead to delays in implementing actions needed to protect patient health. 6. Based on interview and record review, the agency failed to ensure a physician reviewed and signed the patients' plans of care within 30 working days of the patients' start of care as required by State law and the agency's policy and procedure (P&P) titled, “Physician Participation in Plan of Care,” dated November 2023, for five of seven sampled patients (Patients 1, 2, 3, 6, and 7). This failure had the potential to cause delays in physician oversight of the plan of care, which could result in uncoordinated services and unmet patient needs for Patients 1, 2, 3, 6, and 7). 7. Based on interview and record review, the agency failed to ensure the physicians reviewed and signed verbal orders (a directive given by the doctor orally, either in person or over the phone) within 30 working days of the date of the order as required by State law and the agency's policy and procedure (P&P) titled “Verification of Physician Orders,” dated November 2023, for four of seven sampled patients (Patients 2, 3, 6 and 7). This failure had the potential to cause delays in implementing accurate physician‑directed care, increasing the risk of Patients 2, 3, 6, and 7 receiving incorrect, outdated, or unsafe treatments. Findings: 1. During a tour of the agency and an interview on June 1, 2026, at 10 AM with an Intake Coordinator (IC), the agency’s postings were reviewed. The IC confirmed there was no posting of a CLIA certificate. During an interview with the Owner/Administrator Designee (Owner/AD) on June 2, 2026, at 9:39 AM, the Owner/AD stated he was responsible for maintaining and keeping the CLIA certificate current. The Owner/AD stated there was no current CLIA certificate and he did not know how long it had been expired. The Owner/AD stated he had attempted to renew the CLIA certificate in 2024, but nothing had come of it, and he had not followed up on its status. A review of the agency’s policy and procedure (P&P) titled, “Waived Testing,” dated November 2023, indicated, “PURPOSE: To define the organization's compliance with waived testing criteria and the need for a certificate of laboratory services. … PROCEDURE: 1. [name of the agency] will perform permitted laboratory tests in the home. 2. [name of the agency] will apply for and maintain a CLIA waiver on file. …” 2. During a tour of the agency and an interview on June 1, 2026, at 10 AM with an Intake Coordinator (IC), the agency’s postings were reviewed. The IC confirmed there was no posting of a CDPH Lab. Reg. certificate. During an interview with the Owner/Administrator Designee (Owner/AD) on June 2, 2026, at 9:39 AM, the Owner/AD stated he was responsible for maintaining and keeping the CDPH Lab. Reg. certificate current. The Owner/AD stated there was no current CDPH Lab. Reg. certificate and he did not know how long it had been expired. A review of the agency’s policy and procedure (P&P) titled, “Regulatory Compliance,” dated November 2023, indicated, “PURPOSE: To ensure compliance with local, state, federal, and other regulatory bodies. POLICY: The organization will maintain evidence of regulatory compliance, including but not limited to: [CDPH Lab. Reg.] …” During an interview with the Owner/AD and the Admin/DPCS on June 4, 2026, at 10:44 AM, the Owner/AD and Admin/DPCS stated they were members of the Governing Body (GB) and assumed full legal authority and responsibility for the operation of the agency and for the quality of care and services provided. Regarding no posting of a CLIA certificate and no posting of a CDPH Lab. Reg. certificate. The Owner/AD stated he was aware the agency’s CLIA and CDPH Lab registration had expired and that his attempt to renew the CLIA had been unsuccessful from 2024 to June 6, 2026, and he, as a member of the GB, took no further action during this time period to correct the problem. 3. A review of Patient 1’s face sheet (contains demographic and medical information, undated, indicated Patient 1’s start of care date of April 15, 2026, with a certification period of April 15, 2026, to June 13, 2026. Patient 1 had diagnoses which included aftercare following hip joint replacement surgery (removes damaged bone and cartilage in the hip joint and replace them with artificial medical devices). During a concurrent home observation and interview on June 2, 2026, at 10:30 AM, with RN 1, RN 1 took Patient 1’s surgical wound photo with her personal cell phone. RN 1 verified and confirmed she uses her personal cell phone to send and receive patient’s confidential information to the agency without using a secure app, RN 1, further stated that the agency has never provided any secure app to send or receive patients’ confidential information. During an interview on June 3, 2026, at 11:30 AM with the Administrator/Director of Patient Care Services (ADMIN/DPCS), The ADMIN/DPCS confirmed the agency does not use any secure app to send or receive patient’s confidential information, agency staff use their personal cell phones to send and receive patient confidential information. During a concurrent interview and record review on June 3, 2026, at 3:10 PM, with the ADMIN/DPCS, the ADMIN/DPCS reviewed the facility’s undated policy and procedure (P&P) titled, “PATIENT PRIVACY RIGHTS”, dated November 2023. It indicated, “POLICY- ALL AMERICANS CHOICE HOME HEALTH INC. Will respect and safeguard all protected health information of the patients it serves…DEFINITION-Protected health Information (PHI) is any information about health status, provision of health care, or payment for health care that can be linked to a specific individual in ANY form (verbal, written, electronic)”. The ADMIN/DPCS stated the agency did not follow the agency P&P for “Patient Privacy Rights." The Admin/DPCS further stated she was aware that RN 1 had been using her personal cell phone to take pictures of Patient 1’s wound and sending the images to the agency without the secure mobile phone application required to protect Patient 1’s health information, because the agency did not have a secure texting application for RN 1 or other staff to use and allowed the practice to continue. 4. A review of Patient 3’s face sheet (contains demographic and medical information, undated, indicated Patient 3 had a start of care date of April 1, 2026, with a certification period of April 1, 2026, to May 30, 2026. Patient 3 had diagnosis that included obstructive and reflux uropathy (a condition where a urinary tract blockage forces urine to flow backwards into the kidneys), and urinary tract infection (a bacterial infection in the urinary system). a. During a home visit observation on June 2, 2026, at 4:15 PM, with Physical Therapist (PT), and in the presence of Patient 3, PT did not perform hand hygiene (the single most effective way to prevent the spread of germs and infections. It involves washing hands thoroughly with soap and water or using an alcohol-based hand sanitizer) before and after giving care to Patient 3. Furthermore, PT did not follow the clean bag technique (an infection-control protocol designed to prevent the spread of infections between patients) to prevent cross contamination (the transfer of harmful bacteria from one surface to another). PT placed his bag on the floor, and then on Patient 3's bed without use of protective barrier. PT did not wash his hands with soap and water or use any alcohol-based hand rub prior to giving and post care to Patient 3. During an Interview on June 2, 2026, at 4:55 PM, PT stated he should have performed hand hygiene by washing his hands before giving care to Patient 3, with soap and water or alcohol rub and should have used barrier/paper towel for putting his bag on floor or table to prevent cross contamination. PT further stated he forgot to do that, he was focused on the patient and the task he was performing. During an Interview on June 3, 2026, at 10:00 AM, with Director of Patient Care Services (DPCS), the DPCS stated staff were supposed to do hand hygiene before and after giving care to patients and were supposed to use a barrier for them to put their bag and belongings and/or equipment on when in the patient’s home. The DPCS further started PT should have washed/ used alcohol rub to perform hand hygiene and should have not placed his bag on the floor without using protective barrier to prevent cross examination. During a review of the agency’s policy and procedure (P&P) titled, “STANDARD PRECAUTIONS”, dated November 2023, the policy indicated, “PURPOSE-To reduce the risk of exposure of infections when caring for patients…PROCEDURE-General Precautions- Hand Hygiene 1. Hand hygiene will be performed to prevent cross-contamination between the patients and personnel”, and P&P titled, “BAG TECHNIQUE”, dared November 2023, the policy indicated, “PURPOSE- To describe the procedure for maintaining a clean nursing bag/computer bag and preventing cross-contamination…PROCEDURE-Bag Technique-1. The bag will be placed on a clean surface (i.e. a surface that can be easily disinfected) in the car and in the home…5. When a visit is completed, reusable equipment will be cleaned using alcohol, soap and water, or other appropriate solutions, hands will be washed, and equipment and supplies will be returned to the bag…7. If paper towels/newspapers have been used as protective barrier for bag placement in the Patients home, they will be discarded." b. During a concurrent observation and interview on June 3, 2026, at 10:00 AM with licensed vocational nurse/Intake coordinator (IC), in the conference room/medical supplies room, the following medical supplies were found to be expired and were available to use: i. One (1) tube of [Brand] of Menthol and Zinc Ointment (a medication used to soothe and heal irritated skin) with an expiration date of July 2025 (expired for 307 days). ii. One (1) box of 50 [Brand] of short needle insulin syringes (a type of medical device used to give insulin which is a type medication used to lower blood sugar) with an expiration date of May 31, 2026 (expired for 3 days) The IC verified that all the medical supplies were expired and stated it have should have been discarded. A review of the agency’s policy and procedure (P&P) titled, “SAFE AND APPROPRIATE USE OF MEDICAL EQUIPMENT AND SUPPLIES”, dated November 2023. The P&P indicated, “PURPOSE-All home medical equipment and medical supplies will be managed in a safe and appropriate manner….," A review of the P&P titled, “STORAGE OF MEDICATIONS AND NUTRITIONAL THERAPIES”, dated November 2023, the policy indicated, “PROCCEDURE-4. All medications, chemicals, and biologicals will be labelled for contents, with expiration dates clearly identified”. During an interview on June 3 2026, at 1:15 PM, with the Administrator/ Director of Patient Care Services (ADMIN/DPCS), The ADMIN/DPCS stated the medical supplies should have been checked regularly and expired items should have been discarded. The ADMIN/DPCS further stated the agency did not follow the infection prevention control policy. 5. During a review of the Infection Control Program on June 2, 2026, the Administrator/Director of Patient Care Services (Admin/DPCS) provided the annual QAPI committee minutes dated January 10, 2025, for the review of the 2024 Infection Control Program; the annual QAPI committee minutes dated January 9, 2026, for the review of the 2025 Infection Control Program; and the annual QAPI committee minutes dated May 29, 2026, for the review of the 2026 Infection Control Program to date. A review of the QAPI committee minutes dated January 10, 2025, indicated, “The QAPI Committee reviewed agency performance data collected from January 1, 2024, through December 31, 2024. Infection Control Program. Findings reviewed: Zero patient infections. Zero healthcare-associated infections. Zero employee exposure incidents. Zero communicable disease outbreaks. Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” A review of the QAPI committee minutes dated January 9, 2026, indicated, “The QAPI Committee reviewed agency performance data collected from January 1, 2025, through December 31, 2025. Infection Prevention and Control Program. Findings reviewed: Zero patient infections. Zero healthcare-associated infections. Zero employee exposure events. Zero communicable disease outbreaks. Zero infection-related hospitalizations Committee Determination: The Infection Prevention and Control Program was determined to be highly effective.” A review of the QAPI committee minutes dated May 29, 2026, indicated, “Date: May 29, 2026, Time: 1:00 PM - 2:00 PM. The QAPI Committee reviewed: Infection Prevention and Control Program … Findings: Zero infections. …” During a concurrent record review and interview with the Admin/DPCS on June 2, 2026, at 11:30 AM, the Admin/DPCS stated she was responsible for the Infection Control Program. The Admin/DPCS stated she had tried to pull patient infection information from the agency Electronic Medical Record (EMR — a digital version of a patient's paper chart) system; however, it kept indicating zero infections. The Admin/DPCS stated she had been aware this was a problem since the 2024 Infection Control Program review but had not addressed it and continued to report zero patient infections for the 2024 through 2026 review. The Admin/DPCS reviewed the agency’s policy and procedure (P&P) titled, “Evaluating and Maintaining Records of Infections Among Patients,” dated November 2023, and acknowledged the P&P indicated: “PROCEDURE: The Infection Identification-Patient Report form is completed when any of the following occur: A. A new, actual, or suspected infection is clinically observed by personnel B. A culture is ordered and performed, and the results are positive C. A new antibiotic is ordered D. A patient is admitted to a hospital due to an actual or suspected infection E. An unanticipated death due to an actual or suspected infection F. A major permanent loss of function associated with an actual or suspected infection G. A reportable, communicable infection is identified H. Patient has temperatures greater than 101 degrees F [Fahrenheit — a unit of measurement] I. Patient has conjunctivitis [inflammation or infection of the conjunctiva — the clear, thin membrane that covers the white part of the eyeball and the inside of the eyelids.] The Case Manager or the nurse caring for the patient in his/her absence should complete the Infection Identification Patient Report within 24 hours of discovering the infection. Each section of the report should be completed in its entirety. Note: If patient was admitted to home care from a hospital and a new infection was identified by the clinician within the first 48 hours of service, the source of the suspected infection may be nosocomial [an infection that occurs in the hospital]. After completion, the original form will be sent to the Performance Improvement Coordinator, and a copy will be submitted to the appropriate personnel for follow-up. … [The P&P included a blank “Infection Identification-Patient Report,” for use] …” The Admin/DPCS further stated she had not followed the P&P or utilized the “Infection Identification-Patient Report.” In a continued interview on June 4, 20267 at 10:44 AM with owner/AD and Admin/DPCS , the Owner/AD stated he had approved the activities of the Infection Control Program every year from 2024 to June 4, 2026, despite the program reporting zero patient infections year after year. The Owner/AD stated the GB made no inquiry into the Infection Control Program’s activities or took any action to address the results of those activities. The Admin/DPCS stated she was unaware that PT 1 was not performing hand hygiene or adhering to clean bag technique while caring for Patient 3; therefore, the GB had taken no action to correct it. The Admin/DPCS stated she had been unaware that stored medical supplies available for patient use had passed their expiration dates; therefore, the GB had taken no action to correct it. A review of the agency’s policy and procedure titled "Infection Control Plan," dated November 2023, indicated, “PURPOSE: To delineate an infection control plan to meet the following goals: 1. Establish the mechanism by which the organization will address surveillance, prevention, identification, control and reporting of infections, utilizing current scientific methods and epidemiologic principles [the study of how, when, and why diseases and health events spread within groups of people]. … 4. Provide for surveillance systems to track the occurrence and transmission of infections. 5. Comply with all applicable local, state, federal regulations, and accepted standards of practice including, but not limited to: … D. Agency for Healthcare Research and Quality (AHRQ). E. Association for Professionals in Infection Control and Epidemiology (APIC). F. Local regulations including reporting of outbreaks or undue prevalence of infections, parasitic disease or infestation. POLICY: [name of agency] is committed to reducing the risk of acquisition and transmission of health care associated infections (HAIs). Recognized prevention and control mechanisms will be implemented for planning, surveillance, identification, prevention/controls, and reporting procedures. To determine the effectiveness of the infection control plan, [name of agency] will measure, assess, improve, and redesign (as appropriate) the surveillance, identification, prevention, and control function annually through its performance improvement program. …” 6a. A review of Patient 1’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 15, 2026, with a certification period of April 15, 2026, to June 13, 2026. Patient 1 had diagnosis that included aftercare following hip joint replacement surgery (removes damaged bone and cartilage in the hip joint and replace them with artificial implants). A review of Patient 1’s plan of care/physician order dated April 15, 2026, to June 13, 2026, was conducted on June 4, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Fifty days had passed without a physician review and signature). During an interview with the Administrator/Director of Patient Care Services (ADMIN/DPCS) on June 4, 2026, at 9:00 AM, the ADMIN/DPCS stated it was her responsibility to ensure the patients’ plans of care were reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. The ADMIN/DPCS verified Patient 1’s plan of care was not reviewed, approved, and signed by a physician within 30 days of Patient 1’s start of care. 6b. A review of Patients 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of March 30, 2026, with a certification period of March 30, 2026, to May 28, 2026. Patient 2 had diagnoses that included essential hypertension (persistently high blood pressure that is not caused by an underlying medical condition), and generalized muscle weakness. A review of Patient 2’s plan of care/physician order dated March 30, 2026, to May 28, 2026, was conducted on June 4, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Sixty-six days had passed without a physician review and signature). During an interview with the Administrator/Director of Patient Care Services (ADMIN/DPCS) on June 4, 2026, at 9:10 AM, the ADMIN/DPCS stated it was her responsibility to ensure the patients’ plans of care were reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. The ADMIN/DPCS verified Patient 2’s plan of care was not reviewed, approved, and signed by a physician within 30 days of Patient 2’s start of care. 6c. A review of Patient 3’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 1, 2026, with a certification period of April 1, 2026, to May 30, 2026. Patient 3 had diagnosis that included obstructive and reflux uropathy (a condition where a urinary tract blockage forces urine to flow backwards into the kidneys), and urinary tract infection (a bacterial infection in the urinary system). A review of Patient 3’s plan of care/physician order dated April 1, 2026, to May 30, 2026, was conducted on June 4, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (sixty-four days had passed without a physician review and signature). During an interview with the Administrator/Director of Patient Care Services (ADMIN/DPCS) on June 4, 2026, at 9:20 AM, the DPCS stated it was her responsibility to ensure the patients’ plans of care were reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. The ADMIN/DPCS verified Patient 3’s plan of care was not reviewed, approved, and signed by a physician within 30 days of Patient 3’s start of care. 6d. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of February 10, 2026, with a certification period of February 10, 2026, to April 10, 2026. Patient 6 had diagnoses that included hepatic encephalopathy (a decline in brain function that occurs due to severe liver disease). A review of Patient 6’s plan of care/physician’s order dated February 10, 2026, to April 10, 2026, was conducted on June 3, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Seventy-eight working days had passed without a physician’s review and signature). 6e. A review of Patient 7’s plan of care, undated, indicated a start of care date of January 20, 2026, with a certification period of January 20, 2026, to March 20, 2026. Patient 7 had diagnoses that included hypertensive heart disease with heart failure (heart damage caused by long-term high blood pressure that thickens and stiffens the heart muscle, weakening its ability to pump blood and leading to heart failure). A review of Patient 7’s plan of care/physician’s order dated January 20, 2026, to March 20, 2026, was conducted on June 3, 2026. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Ninety-three working days had passed without a physician’s review and signature). During an interview with an Intake Coordinator (IC), the Administrator/Director of Patient Care Services (Admin/DPCS), and the Owner/Administrator Designee (Owner/AD) on June 3, 2026, at 3:15 PM, the IC stated he electronically faxed (e‑faxed) the physicians their patient’s plans of care/physician’s orders, but it would take months to receive the plans of care/physician’s orders back with the physician’s signatures. The IC stated he had discussed the problem with management but had not received direction to do anything differently than the e‑fax. The Admin/DPCS and Owner/AD stated they received all of their patients from one Acute Care Hospital (ACH), and they had a continual problem getting the plans of care/physician’s orders signed by the physicians referring the patients to the home health agency. The Admin/DPCS stated she was aware the regulatory requirement required the patients’ plans of care/physician’s orders to be reviewed and signed by the physician within 30 working days but had not brought the problem to the attention of the Quality Assessment and Performance Improvement (QAPI) Program, and there was no action plan to address the problem. A review of Title 22: § 74697. Plan of Treatment; Plan of Care; Plan for Personal Care Services, indicated, “(a) A written plan of treatment (or plan of care for home health agencies participating in the Medicare and/or Medi-Cal program) shall be established for each patient whose care requires medical orders. A plan of treatment or plan or care for patients requiring medical orders shall be: (1) Approved and signed within 30 working days by the attending physician, dentist, podiatrist. or other licensed and legally authorized practitioner within his or her scope of practice.” A review of the agency's policy and procedure, titled “Physician Participation in Plan of Care,” dated November 2023, indicated, “PURPOSE: To provide guidelines for the physician's (or other authorized licensed independent practitioner's) participation in home health care services. POLICY: A physician (or other authorized licensed independent practitioner) will direct the care of every home health care patient admitted for service. The attending physician (or other authorized licensed independent practitioner) will certify that medical, skilled, rehabilitative, and social services provided by the organization are medically necessary and meets the requirements to be covered by Medicare. The attending physician (or other authorized licensed independent practitioner) will participate in the care planning process by initiating, reviewing and revising therapeutic and diagnostic orders. The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practice. … PROCEDURE: … The attending physician (or other authorized licensed independent practitioner) will sign the plan of care/treatment within 30 days of the start of care. …” 7a. A review of Patients 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of March 30, 2026, with a certification period of March 30, 2026, to May 28, 2026. Patient 2 had diagnoses that included essential hypertensin (persistently high blood pressure that is not caused by an underlying medical condition), and generalized muscle weakness. i. Patient 2’s admission order dated April 8, 2026. (fifty-seven days had passed without physicians’ signature). ii. Patient 2’s verbal order dated April 8, 2026, indicated CHHA (certified home health aide) visit frequencies of one time a week for eight weeks. (fifty-seven days had passed without physicians’ signature). iii. For Patient 2, the care plan did not include CHHA visits frequencies and was not reviewed, approved, and signed by a physician within 30 days of the patient’s resumption of care. During an interview with the Administrator/Director of Patient Care Services (ADMIN/DPCS) on June 4, 2026, at 9:35 AM, the DPCS verified Patient 2’s, CHHA visit frequency order had not been signed by the physician within 30 working days. 7b. A review of Patient 3’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 1, 2026, with a certification period of April 1, 2026, to May 30, 2026. Patient 3 had diagnosis that included obstructive and reflux uropathy (a condition where a urinary tract blockage forces urine to flow backwards into the kidneys), and urinary tract infection (a bacterial infection in the urinary system (kidneys, ureters, bladder, and urethra). i. Patient 3’s admission order dated April 1, 2026, to May 30, 2026 (sixty-four days had passed without a physician review and signature). ii. Patient 3’s verbal order dated March 31, 2026, indicated Physical Therapy (PT) for evaluation and treatment (sixty-five days had passed without physicians’ signature). iii. For Patient3, the care plan did not include PT evaluation and treatment visit and was not reviewed, approved, and signed by a physician within 30 days of the patient’s resumption of care. During an interview with the Administrator/Director of Patient Care Services ADMIN/DPCS) on June 4, 2026, at 9:45 AM, the DPCS verified Patient 3’s PT visit frequency order had not been signed by the physician within 30 working days. 7c. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of February 10, 2026, with a certification period of February 10, 2026, to April 10, 2026. Patient 6 had diagnoses that included hepatic encephalopathy (a decline in brain function that occurs due to severe liver disease). A review of Patient 6’s verbal physician orders on June 3, 2026, was conducted. There was no documented evidence to show the following verbal physician orders had been signed by a physician: i. Admission order dated February 6, 2026. (Eighty working days had passed without a physician’s signature). ii. Transfer to inpatient facility does not discharge dated February 12, 2026. (Seventy-four working days had passed without a physician’s signature). iii. Discharge while inpatient dated February 26, 2026. (Sixty working days had passed without a physician’s signature). 7d. A review of Patient 7’s plan of care, undated, indicated a start of care date of January 20, 2026, with a certification period of January 20, 2026, to March 20, 2026. Patient 7 had diagnoses that included hypertensive heart disease with heart failure (heart damage caused by long-term high blood pressure that thickens and stiffens the heart muscle, weakening its ability to pump blood and leading to heart failure). A review of Patient 7’s verbal physician orders on June 3, 2026, was conducted. There was no documented evidence to show the following verbal physician orders had been signed by a physician: i. Discharge Patient dated February 13, 2026. (Seventy-three working days had passed without a physician’s signature). During an interview with an Intake Coordinator (IC), the Administrator/Director of Patient Care Services (Admin/DPCS), and the Owner/Administrator Designee (Owner/AD) on June 3, 2026, at 3:15 PM, the IC stated he electronically faxed (e‑faxed) the physicians their patient’s plans of care/physician’s orders, but it would take months to receive the plans of care/physician’s orders back with the physician’s signatures. The IC stated he had discussed the problem with management but had not received direction to do anything differently than the e‑fax. The Admin/DPCS and Owner/AD stated they received all of their patients from one Acute Care Hospital (ACH), and they had a continual problem getting the plans of care/physician’s orders signed by the physicians referring the patients to the home health agency. The Admin/DPCS stated she was aware the regulatory requirement required the patients’ plans of care/physician’s orders to be reviewed and signed by the physician within 30 working days but had not brought the problem to the attention of the Quality Assessment and Performance Improvement (QAPI) Program, and there was no action plan to address the problem. A review of Title 22: § 74697. Plan of Treatment; Plan of Care; Plan for Personal Care Services, indicated, “(a) A written plan of treatment (or plan of care for home health agencies participating in the Medicare and/or Medi-Cal program) shall be established for each patient whose care requires medical orders. A plan of treatment or plan or care for patients requiring medical orders shall be: (1) Approved and signed within 30 working days by the attending physician, dentist, podiatrist. or other licensed and legally authorized practitioner within his or her scope of practice.” A review of the agency's policy and procedure titled “Verification of Physician Orders,” dated November 2023, indicated, “PURPOSE: To ensure that accurate physician (or other authorized licensed independent practitioner) orders are obtained in accordance with applicable law and regulation. POLICY: Orders will be obtained from a licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients. … PROCEDURE: 1. An order or prescription will be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy if permitted by law, or the direct transcription of a verbal order. 2. All telephone orders will be received and processed in accordance with state and federal laws and regulations. 3. All telephone orders or verbal orders will be "read back" to the physician (or other authorized licensed independent practitioner) or designee to assure accuracy. 4. Orders will be documented on a form provided by [name of the agency] dated and signed by the professional receiving the order. 5. A copy of the physician's (or other authorized licensed independent practitioner's) order will be kept in the clinical record. 6. The original of the order form will be delivered to the physician (or other authorized licensed independent practitioner) for signature. 7. When the signed order form is returned to [name of the agency], the copy will be removed from the clinical record and destroyed, and the original will be retained in the clinical record. 8. Signed orders will be in the clinical record within 30 days of initiation of care or interim order, unless otherwise specified by applicable state law and regulation.” In a continued interview, regarding numbers 6 and 7, the Owner/AD and Admin/DPCS stated they were aware of the problem of not being able to obtain physician signatures within 30 working days on the patients’ plans of care and verbal orders for the past three years; however, they never questioned why the problem was not addressed by the QAPI Program, and the GB took no documented action to correct or mitigate the problem. A review of the agency’s policy and procedure titled “Governing Body,” dated November 2023, indicated “PURPOSE: To outline the roles and responsibilities of the Governing Body. POLICY: The Governing Body will assume full legal authority, responsibility, decision-making and accountability for the overall management and operations, the provision of services, fiscal operations, human resource management, review of the organization's budget and operational plans, and its quality assessment and performance improvement (QAPI) program. The Governing Body of [name of agency] will serve as the governing authority for the home care program, which will function according to [name of the agency] bylaws. PROCEDURE: … 3. The Governing Body will appoint a Governing Body committee to work with Senior Leadership and the Performance Improvement Committee to review and develop policies and procedures consistent with the organization's mission; annually review and revise policies and procedures; prepare an annual evaluation of [name of the agency] in relation to its mission; and assist in identifying goals and measuring accomplishments of the organization's operations. … 9. The Governing Body will appoint a qualified Executive Director/Administrator and establish procedures of systematic communication between the two. Performance of the Executive Director/Administrator will be monitored annually through a procedure established by the Governing Body. The process and documentation will reflect that: A. Relevant findings of performance improvement activities are consistently provided to the Governing Body to allow for oversight of the quality assessment and performance improvement (QAPI) program. The governing body will ensure the following: 1. That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; 2. That the organizational-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; 3. That clear expectations for patient safety are established, implemented, and maintained; and 4. That any findings of fraud or waste are appropriately addressed. B. Other information relevant to the quality of patient care (i.e., unusual occurrences in care delivered) is also consistently provided through a defined process. 10. The Governing Body will authorize adequate resources and support to establish and maintain an organization-wide performance improvement program. Information related to the performance improvement program will be provided to the Governing Body. … 14. The Governing Body will evaluate the organization's performance on a regular basis. …”

The following reflects the findings of the California Department of Public Health during a recertification survey conducted May 08, 2023, through May 11, 2023. Representing the Department: Surveyors: 35183, 47110 Census: 50 Unduplicated Admissions: 122 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 No deficiencies were issued for Emergency Preparedness for All Americans Choice Home Health.

The following reflects the findings of the California Department of Public Health during a recertification survey conducted May 08, 2023, through May 11, 2023. Representing the Department: Surveyors: 35183, 47110 Census: 50 Unduplicated Admissions: 122 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 The following Conditions of Participation were not met: G 510 484.55 Comprehensive assessment of patients G 570 484.60 Care planning, coordination, quality of care G 640 Quality assessment/performance improvement

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: The agency failed to ensure the Condition of Participation: G 510 484.55 Comprehensive Assessment of Patients was in compliance when: 1. Based on interview, and record review, the agency failed to ensure the patients' initial assessment was completed within 48 hours of the patients’ referral order for three of seven sampled patients (Patients 2, 3, and 5). (Refer to G 514) 2. Based on interview, and record review, the agency failed to ensure the patients’ comprehensive assessments were completed within five (5) days of the start of care for two of seven sampled patients (Patients 6 and 7) when Patients 6 and 7 did not receive an initial Physical Therapy (PT) evaluation within five (5) days of their respective starts of care. (Refer to G 518) 3. Based on interview, and record review, the agency failed to ensure a review of all medications the patients were taking was conducted for one of seven sampled patients (Patient 1) when: For Patient 1: the Medication Profile (MP-a current list of all medications prescribed for a specific patient), indicated the wrong dose for three medications (losartan potassium a blood pressure lowering medication, colehicine-probenecid a medication to treat gout [a disease that causes joint pain], and Metformin hydrochloride (HCL) a medication to control high blood sugar). (Refer to G 536) 4. Based on interview, and record review, the agency failed to conduct a recertification assessment (an assessment to determine if home health services continue to be required by a patient for another 60-day period) within the last five days of the 60-recertification period for one of seven sampled patients (Patient 4). (Refer to G 546) 5. Based on interview, and record review, the agency failed to ensure the discharge assessment and transfer summary was provided to the receiving agency within two days of the discharge for one of seven sampled patients (Patient 7) when Patient 7 was discharged to another home health agency. (Refer to G 550) The cumulative effect of these systemic practices resulted in the potential to cause Patients 2, 3, 4, 5, 6, and 7 to suffer a delay in the determination of their immediate care and support needs and for their care and support needs to go unmet. Patient 1 had the potential to suffer ineffective drug therapy, significant side effects and noncompliance with drug therapy and Patient 7 to suffer a break in the continuity of care during the discharge/transfer between the two home health agencies.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the patients' initial assessment was completed within 48 hours of the patients’ referral order for three of seven sampled patients (Patients 2, 3, and 5). This failure had the potential to cause a delay in the determination of Patients 2, 3, and 5’s immediate care and support needs. 1. A review of Patient 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of March 31, 2023, with a certification period of March 31, 2023, to May 29, 2023. Patient 2 had diagnoses that included acute kidney failure (a condition in which the kidneys suddenly cannot filter waste from the blood). A review of Patient 2’s referral order dated March 13, 2023, indicated to evaluate patient for admission to home health services. A review of Patient 2’s initial assessment dated March 31, 2023, indicated the initial assessment had been conducted on March 31, 2023. (The initial assessment had been completed 18 days after the physician’s referral order) During an interview with the Director of Patient Care Services (DPCS) and the Nurse Case Manager/Intake (CM/I), on May 10, 2023, at 9:20 AM, the DPCS and CM/I verified Patient 2 had not received the initial assessment within 48 hours of the referral order and should have. 2. A review of Patient 3’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 12, 2023, with a certification period of April 12, 2023, to June 10, 2023, indicated Patient 3 had diagnoses that included diabetes mellitus (a disease that causes high blood sugar levels). A review of Patient 3’s referral order dated April 7, 2023, indicated to evaluate patient for admission to home health services. A review of Patient 3’s initial assessment dated April 12, 2023, indicated the initial assessment had been conducted on April 12, 2023. (The initial assessment had been completed five days after the physician’s referral order) During an interview with the Director of Patient Care Services (DPCS) and the Nurse Case Manager/Intake (CM/I), on May 11, 2023, at 1:45 PM, the DPCS and CM/I verified Patient 3 had not received the initial assessment within 48 hours of the referral order and should have. 3. A review of Patient 5’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 17, 2023, with a certification period of April 17, 2023, to June 15, 2023. Patient 5 had diagnoses that included hip replacement surgery. A review of Patient 5’s referral order dated April 13, 2023, indicated, “Order Information: To Service: …Skilled Home Care …Orderable Item: …Skilled Home Care …Type of Service: Evaluation and Treatment. Date of Procedure: Apr [April] 10, 2023, Discharge date: 04/11/2023 [April 11, 2023], Start Therapy: 04/13/2023 [April 13, 2023] … Physical Therapy, Home Safety/Fall Risk Assessment Prosthetic [an artificial body part]/Orthotic [artificial support or brace] Evaluation, Fall Prevention, Gait training [therapy that helps strengthen and improve a patient’s walk and stance], establish home exercise program, Other (explained below) WBAT [weight-bearing status as tolerated] /Modalities [the administration of thermal, mechanical, electromagnetic and light energies for therapeutic purposes] as needed.” A review of Patient 5’s initial assessment dated April 17, 2023, indicated the initial assessment had been conducted on April 17, 2023. (The initial assessment had been completed four days after the physician’s referral order.) During an interview with the Director of Patient Care Services (DPCS) and a Case Manager/Intake (CM/I) on April 10, 2023, at 10:57 AM, The DPCS confirmed the referral order indicated the initial assessment was supposed to start on April 13, 2023. The CM/I stated when she called Patient 5 to set up the admission visit Patient 5 had requested to be admitted on April 17, 2023, because he was fine and did not need help. CM/I stated she did not reach out to the surgeon to approve the initial assessment date of April 17, 2023, instead of April 13, 2023. The DPCS stated CM/I should have informed her that Patient 5 was not being admitted on the ordered April 13, 2023, date. The DPCS stated Patient 5's surgeon needed to “OK” the start of services 4 days later then he had originally ordered. A review of the agency’s policy and procedure titled, “Initial and Comprehensive Assessment,” dated April 2020, indicated, “PURPOSE: To provide guidelines for the initial assessment of patients admitted to service and for completing the plan of care. POLICY: An initial patient assessment will be performed and documented in the patient's clinical record by a registered nurse, physical therapist, or speech therapist. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient's return home, on the start of care date ordered by the physician (or other authorized licensed independent practitioner), or at the patient/family request with the approval of the physician (or other authorized licensed independent practitioner).”

Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the patients’ comprehensive assessments were completed within five (5) days of the start of care for two of seven sampled patients (Patients 6 and 7) when Patients 6 and 7 did not receive an initial Physical Therapy (PT) evaluation within five (5) days of their respective starts of care. This failure had the potential to cause Patient 6 and 7’s needs to go unmet. 1. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of January 12, 2023, with a certification period of January 12, 2023, to March 12, 2023. Patient 6 had diagnoses that included pressure ulcer (a sore caused by prolonged pressure). A review of Patient 6’s plan of care/physician’s order dated January 12, 2023, to March 12, 2023, indicated, Physical Therapy (PT) evaluation and follow up. A review of Patient 6’s “Physical Therapy Evaluation,” dated January 20, 2023, indicated, the initial evaluation has been conducted on January 20, 2023. (The initial PT evaluation has been completed eight days after Patient 6’s start of care) During an interview with the Director of Patient Care Services (DPCS) on May 8, 2023, at 11:20 AM, the DPCS stated the PT evaluation was not done within five days from the start of care and should have been. 2. A review of Patient 7’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of December 24, 2022, with a certification period of December 24, 2022, to February 21, 2023. Patient 7 had diagnoses that included hypertensive heart disease (heart disease caused by high blood pressure). A review of Patient 7’s plan of care/physician’s order dated December 24, 2022, to February 21, 2023, indicated, Physical Therapy (PT) evaluation and follow up. A review of Patient 7’s “Physical Therapy Evaluation,” dated December 30, 2022, indicated, the initial evaluation has been conducted on December 30, 2022. (The initial PT evaluation has been completed six days after Patient 7’s start of care) During an interview with the Director of Patient Care Services (DPCS) on May 8, 2023, at 1:25 PM, the DPCS stated the PT evaluation was not done within five days from the start of care and should have been. A review of the agency’s policy and procedure titled, “Initial and Comprehensive Assessments,” dated April 2020, indicated, “…A comprehensive patient assessment will be completed within five (5) calendar days of the patient’s start of care…”

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to ensure a review of all medications the patients were taking was conducted for one of seven sampled patients (Patient 1) when: For Patient 1: the Medication Profile (MP-a current list of all medications prescribed for a specific patient), indicated the wrong dose for three medications (losartan potassium a blood pressure lowering medication, colehicine-probenecid a medication to treat gout [a disease that causes joint pain], and Metformin hydrochloride (HCL) a medication to control high blood sugar). This failure had the potential to cause Patient 1 to suffer ineffective drug therapy, significant side effects and noncompliance with drug therapy. A review of Patient 1’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of February 10, 2023, with a recertification period of April 11, 2023, to June 9, 2023. Patient 1 had diagnoses that included polyosteoarthritis (a disease that causes pain and inflammation in five or more joints). During a home visit on May 9, 2023, with Licensed Vocational Nurse (LVN 1) and in the presence of Patient 1, an observation of Patient 1’s actual medication bottles available in the home were compared with Patient 1’s most current Medication Profile (MP). During a concurrent observation and interview on May 9, 2023, at time 1:40 PM, with LVN 1 and Patient 1, a bottle indicated losartan potassium 100 mg (milligrams-a unit if measurement) tablet, oral, 1 (one)-tablet, once daily. Patient 1’s MP indicated losartan potassium 50 mg tablet, 1 (one)-tablet once daily. A bottle indicated colchicine-probenecid 0 (zero).6 (six) mg, oral, 1 (one)-tablet, two times daily. Patient 1’s MP indicated colchicine-probenecid 0 (zero).5 (five)-500 mg, oral, 1 (one)-table as needed. A bottle indicated Metformin hydrochloride (HCL) 1000 mg tablet, oral, one tablet two times a day. Patient 1’s MP indicated Metformin hydrochloride (HCL) 500 mg tablet, oral, one tablet two times a day. During an interview with Patient 1on May 9, 2023, at 1:40 PM. Patient 1 stated the Metformin and losartan potassium dosage had changed two months ago. Patient 1 stated he took the colchiscine-probenecid as directed on the bottle. Patient 1 stated every time there was a change in his medication, he let the home health agency know. During an interview with LVN 1 on May 9, 2023, at 2:00 PM, LVN 1 stated nurses were expected to conduct medication reconciliation at every visit and report to the agency if they identified a discrepancy during medication reconciliation. LVN 1 verified the doses for losartan potassium, colehicine-probenecid, and Metformin hydrochloride (HCL) indicated on the MP did not match the doses indicated on the pharmacy labels. During an interview with the Director of Patient Care Services (DPCS) on May 9, 2023, at 3:40 PM, the DPCS stated her expectation was that the LVNs would ask about changes or updates to the patients’ medications and perform medication reconciliation at least once a week. The DPCS stated this did not happen for Patient 1 because the losartan potassium, colchicine-probenecid and Metformin hydrochloride (HCL) orders on the medication profile were incorrect. A review of the agency’s policy and procedure titled, “Medication Profile,” dated April 2020, indicated, “POLICY: Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications.”

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to conduct a recertification assessment (an assessment to determine if home health services continue to be required by a patient for another 60-day period) within the last five days of the 60-recertification period for one of seven sampled patients (Patient 4). This failure had the potential to cause a delay in identifying Patient 4’s care and support needs. A review of Patient 4’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of January 31, 2023, with a recertification period of April 1, 2023, to May 30, 2023. Patient 4 had diagnoses that included diabetes mellitus (a disease that causes high blood sugar levels). A review of Patient 4’s initial assessment dated January 31, 2023, indicated Patient 4’s first 60 day certification period was from January 31, 2023 to March 31, 2023. A review of Patient 4’s recertification assessment dated April 5, 2023, indicated Patient 4’s second 60 day certification period was from April 1, 2023, to May 30, 2023. (The window for the agency to conduct Patient 4’s recertification assessment was from March 28, 2023, to April 1, 2023. The agency conducted Patient 4’s recertification assessment four days late). During an interview with the Director of Patient Care Services (DPCS) and a Case Manager/Intake (CM/I) on April 10, 2023, at 9:37 AM, the DPCS verified Patient 4’s recertification assessment should have been conducted between March 28, 2023, and April 1, 2023, and had not. CM/I stated she was unable to schedule the recertification assessment on the last five days of the certification period due to the patient not feeling well. CM/I stated she should have reached out to the doctor with a verbal order for the recertification assessment to be conducted on April 5, 2023, and did not. The DPCS stated the CM/I should have reported to her that the recertification assessment could not be done between March 28, 2023, and April 1, 2023, and the CM/I should have obtained an order for the recertification assessment to be conducted on April 5, 2023, and had not. A review of the agency’s policy and procedure titled, “Reassessments/Recertification,” dated April 2020, indicated, “PURPOSE: To outline the requirements for ongoing updates to the comprehensive assessment (reassessments) and recertification. POLICY: The comprehensive assessment must be updated and revised every 60 days beginning with the start of care. A comprehensive assessment, including all required OASIS data elements, must be performed to measure patient progress towards outcomes. …PROCEDURE: …2. For each new episode of care, a comprehensive assessment will be completed no earlier than five (5) days before and no later than one (1) day before the calendar day on which the new episode of care will begin.”

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to ensure the discharge assessment and transfer summary was provided to the receiving agency within two days of the discharge for one of seven sampled patients (Patient 7) when Patient 7 was discharged to another home health agency. This failure caused a break in Patient 7’s continuity of care when the Home Health Agency staff were unaware of the care and services the home health agency had provided; Patient 7’s current physical and psychosocial status; Patient 7’s reconciled medication list; advance directives, and continuing symptom management needs. A review of Patient 7’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of December 24, 2022, with a certification period of December 24, 2022, to February 21, 2023. Patient had diagnoses that included hypertensive heart disease (heart disease caused by high blood pressure). A review of Patient 7’s physician’s order dated January 2, 2023, indicated “discharge status: to home care of another organized home health service organization…” A review of Patient 7’s Discharge/Transfer Summaries from January 2, 2023, to May 8, 2023, was conducted. There was no documented evidence to show a Discharge/Transfer Summary had been completed or sent to the receiving home health agency. (One hundred and twenty-six days had passed without a Discharge/Transfer Summary having been completed or sent to the receiving home health agency). During an interview with the Director of Patient Care Services (DPCS) on May 8, 2023, at 1:50 PM, the DPCS stated there was a request from Patient 7’s son for Patient 7 to be transferred to another home health agency but they (the agency) did not know which home health agency Patient 7 had been transferred to. The DPCS stated a transfer summary had not been provided to the receiving home health agency. A review of the agency’s policy and procedure titled, “Transfer Summary,” dated, revised, April 2020, indicated, “Policy. All patients transferred from the organization will have a transfer summary completed and filed in the clinical record…Procedure. 1. Within 48 hours of transfer, the transferring clinician will complete a transfer summary…2. Completed transfer summaries will be given to a clinical records clerk, who will send a copy to the receiving organization, along with a copy of the clinical record, within two (2) business days of a planned transfer or within two (2) days of becoming aware of an unplanned transfer and will file the original in the clinical record. 3. A copy of the transfer summary will be sent to the physician within 48 hours of transfer…”

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: The agency failed to ensure that the Condition of Participation: G 570 484.60: Care planning, coordination, quality of care was in compliance as follows: 1. Based on interview and record review, the agency failed to ensure an individualized plan of care was developed within five days and reviewed, approved, and signed by a physician within 30 days of the patient’s start of care for four of seven sampled patients (Patients 2, 4, 6 and 7) when: a. For Patient 2, the plan of care was not reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. (Refer to G 572) b. For Patient 4, the plan of care was not reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. (Refer to G 572) c. For Patient 6, the care plan did not include Skilled Nursing (SN) visit frequencies and was not reviewed, approved, and signed by a physician within 30 days of the patient’s resumption of care. (Refer to G 572) d. For Patient 7, the plan of care was not reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. (Refer to G 572) 2. Based on interview, and record review, the agency failed to obtain signed physician orders before providing home health services for two of seven sampled patients (Patients 2 and 6) when: a. For Patient 2, Physical Therapy (PT) visits were made without a physician's order. (Refer to G 580) b. For Patient 6, Physical Therapy (PT) visits and Skilled Nursing (SN) visits were made without a physician's order. (Refer to G 580) 3. Based on interview, and record review, the agency failed to ensure verbal orders were signed, within 30 working days, for one of seven sampled patients (Patient 7). (Refer to G 584) The cumulative effect of these systemic practices resulted in patients receiving care and services not reviewed and approved by a physician.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure an individualized plan of care was developed within five days and reviewed, approved, and signed by a physician within 30 days of the patient’s start of care for four of seven sampled patients (Patients 2, 4, 6 and 7) when: 1. For Patient 2, the plan of care was not reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. 2. For Patient 4, the plan of care was not reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. 3. For Patient 6, the care plan did not include Skilled Nursing (SN) visit frequencies and was not reviewed, approved, and signed by a physician within 30 days of the patient’s resumption of care. 4. For Patient 7, the plan of care was not reviewed, approved, and signed by a physician within 30 days of the patient’s start of care. This failure caused the agency to provide care that was not care planned or reviewed and approved by a physician. 1. A review of Patient 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of March 31, 2023, with a certification period of March 31, 2023, to May 29, 2023. Patient 2 had diagnoses that included acute kidney failure (a condition in which the kidneys suddenly cannot filter waste from the blood). A review of Patient 2’s plan of care/physician’s order dated March 31, 2023, to May 29, 2023, was conducted on May 10, 2023. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Forty days had passed without a physician’s review and signature). During an interview with the Director of Patient Care Services (DPCS) on May 10, 2023, at 9:00 AM, the DPCS stated it was her responsibility to ensure the patients’ plans of care were reviewed, approved, and signed by a physician within 30 days of the patients’ start of care. The DPCS verified Patient 2’s plan of care was not reviewed, approved, and signed by a physician within 30 days of Patient 2’s start of care. 2. A review of Patient 4’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of January 31, 2023, with a recertification period of April 1, 2023, to May 30, 2023. Patient 4 had diagnoses that included diabetes mellitus (a disease that causes high blood sugar levels). A review of Patient 4’s plan of care/physician’s order dated April 1, 2023, to May 30, 2023, was conducted on May 10, 2023. There was no documented evidence to show the physician had reviewed and signed the plan of care. (Thirty-nine days had passed without a physician’s review and signature). During an interview with the Director of Patient Care Services (DPCS) on May 10, 2023, at 9:37 AM, the DPCS stated the care plan/physician’s order was supposed to be reviewed and signed by the physician within 30 days and it was not. 3. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of January 12, 2023, with a certification period of January 12, 2023, to March 12, 2023. Patient 6 had diagnoses that included a pressure ulcer (a sore caused by prolonged pressure). A review of patient 6’s plan of care/physician’s order dated January 12, 2023, to March 12, 2023, was conducted on May 8, 2023. There was no documented evidence to show Physical Therapy (PT) visits frequencies or that the physician had reviewed and signed the plan of care. (One hundred and sixteen days had passed without a physician’s review and signature) During an interview with the Director of Patient Care Services (DPCS) on May 8, 2023, at 12:10 PM. DPCS verified the plan of care did not indicate PT visit frequencies and the plan of care had not been reviewed, approved, and signed by a physician within 30 days of Patient 6’s start of care. 4. A review of patient 7’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date December 24, 2022, with a certification period of December 24, 2022, to February 21, 2023. Patient 7 had diagnoses that included hypertensive heart disease (heart disease caused by high blood pressure). A review of patient 7’s plan of care/physician’s order dated December 24, 2022, to February 21, 2023, was conducted on May 8, 2023. There was no documented evidence to show the physician had reviewed and signed the plan of care. (One hundred and thirty-five days had passed without a physician’s review and signature) During an interview with the Director of Patient Care Services (DPCS) on May 8, 2023, at 1:04 PM, The DPCS verified Patient 7’s plan of care was not reviewed, approved, and signed by a physician within 30 days of Patient 7’s start of care. A review of the agency’s policy and procedure titled, “Physician Participation in Plan of Care,” dated April 2020, indicated, “PURPOSE: To provide guidelines for the physician's participation in home health care services. POLICY: A physician will direct the care of every home health care patient admitted for service. The attending physician will certify that medical, skilled, rehabilitative, and social services provided by the organization are medically necessary and meets the requirements to be covered by Medicare. The attending physician will participate in the care planning process by initiating, reviewing and revising the plan of care (therapeutic and diagnostic orders). The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practice. … PROCEDURE: 1. Physician (or other authorized licensed independent practitioner) orders will be individualized, based on patient's needs, and include: A. Patient diagnoses, B. Treatments and/or procedures needed, including type, frequency, duration, and goals, C. Medications to be administered and/or monitored, D. A description of equipment and related supplies provided by the organization, E. A description of any medical, physical, psychosocial, or environmental precautions, limitations, and activities permitted. …5. The attending physician will sign the plan of care/treatment within 30 days of the start of care [or recertification of care].”

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to obtain signed physician orders before providing home health services for two of seven sampled patients (Patients 2 and 6) when: 1. For Patient 2, Physical Therapy (PT) visits were made without a physician's order. 2. For Patient 6, Physical Therapy (PT) visits and Skilled Nursing (SN) visits were made without a physician's order. This failure caused the agency to provide unauthorized and unapproved clinical services to Patients 2 and 6. 1. A review of Patient 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of March 31, 2023, with a certification period of March 31, 2023, to May 29, 2023. Patient 2 had diagnoses that included acute kidney failure (a condition in which the kidneys suddenly cannot filter waste from the blood). A review of Patient 2’s “Physical Therapy [PT] Evaluation,” dated April 3, 2023, indicated recommended PT visit frequencies of two visits per week for four weeks. A review of Patient 2’s physician’s orders from March 31, 2023, to May 29, 2023, was conducted. There was no documented evidence to show a physician’s order for the PT’s recommended visit frequencies. A review of Patient 2’s PT visit notes from March 31, 2023, to May 29, 2023, was conducted. The PT visit notes indicated a PT visited Patient 2 on April 3, 2023, April 6, 2023, and April 10, 2023. During an interview with a Case Manager/Intake (CM/I) on May 10, 2023, at 9:30 AM, CM/I stated there was no physician’s signature on Patient 2’s PT evaluation where the visit recommendations were indicated. CM/I stated due to the missing signature there was no physician’s order for PT visit frequencies. 2. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of January 12, 2023, with a certification period of January 12, 2023, to March 12, 2023. Patient 6 had diagnoses that included a pressure ulcer (a sore caused by prolonged pressure). A review of Patient 6’s “Physical Therapy [PT] Evaluation,” dated January 20, 2023, did not indicate recommended PT visit frequencies. A review of Patient 6’s physician’s orders from January 20, 2023, to May 10, 2023, was conducted. There was no documented evidence to show a physician’s order for PT visit frequencies. A review of Patient 6’s PT visit notes from January 20, 2023, to May 10, 2023, was conducted. The PT visit notes indicated a PT visited Patient 6 on January 24, 2023, and January 26, 2023. During an interview with the Director of Patient Care Services (DPCS) on May 10, 2023, at 11:40 AM, the DPCS stated the PT did not recommend visit frequencies and a physician’s order for PT visit frequencies had not been obtained. The DPCS stated the PT should not have visited Patient 6 without an order. A review of Patient 6’s Resumption of Care, Care Plan, dated February 9, 2023, was conducted. There was no documented evidence to show a Skilled Nursing (SN) visit frequency. A review of Patient 6’s physician’s orders from February 9, 2023, (date of the resumption of care assessment) to May 10, 2023, was conducted. There was no documented evidence to show a physician’s order for SN visit frequencies after Patient 6’s resumption of care. A review of Patient 6’s SN visit notes from February 9, 2023, to May 10, 2023, was conducted. The SN visit notes indicated an SN visited Patient 6 on January 16, 2023, and January 18, 2023. During an interview with the DPCS on May 10, 2023, at 12:10 PM, the DPCS stated Patient 6’s care plan should have been updated with SN visit frequencies after the resumption of care and it had not. The DPCS verified an SN had made visits to Patient 6 without a physician’s order. A review of the agency’s policy and procedure titled, “Admission Criteria and Process,” dated April 2020, indicated, “…The patient must be under the care of a physician. The patient’s physician (or other authorized licensed independent practitioner) must order and approve the provision of any service. A skilled service must be ordered.”

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to ensure verbal orders were signed, within 30 working days, for one of seven sampled patients (Patient 7). This failure resulted in Patient 7 receiving services and procedures not authorized and approved by a physician. A review of Patient 7’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of December 24, 2022, with a certification period of December 24, 2022, to February 21, 2023. Patient 7 had diagnoses that included hypertensive heart disease (heart disease caused by high blood pressure). A review of Patient 7’s physician’s orders from December 23, 2022, to May 8, 2023, was conducted. There was no documented evidence to show the following physician’s orders had been signed by the physician within 30 working days of the order: a. Patient 7’s admission order dated December 23, 2022. (One hundred and thirty-five working days had passed without a physician’s signature) b. Patient 7’s verbal order, dated December 24, 2022, indicated Skilled Nursing (SN) visit frequencies of one time a week for one week, two times a week for two weeks, and one time a week for six weeks (One hundred and thirty-five working days had passed without a physician’s signature) c. Patient 7’s verbal order, dated December 24, 2022, indicated Physical Therapy (PT) visit frequencies of one time a week for one week and two times a week for four weeks. (One hundred and thirty-five working days had passed without a physician’s signature) d. Patient 7’s discharge/transfer order, dated January 2, 2023 (One hundred and twenty-six working days had passed without a physician’s signature) During an interview with the Director of Patient Care Services (DPCS) on May 8, 2023, at 1:25 PM, the DPCS verified Patient 7’s admission order, SN visit frequency order, PT visit frequency order and discharge/transfer order had not been signed by the physician within 30 working days. A review of the agency’s policy and procedure titled “Verification of Physician Orders,” dated April 2020, indicated, “PURPOSE: To ensure that accurate physician (or other authorized licensed independent practitioner) orders are obtained in accordance with applicable law and regulation. POLICY: Orders will be obtained from a licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients. … 8. Signed orders will be in the clinical record within 30 days of initiation of care or interim order, unless otherwise specified by applicable state law and regulation. …”

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: The agency failed to ensure that the Condition of Participation: G 640 484.65 Quality assessment and performance improvement (QAPI) was in compliance as follows: 1. Based on interview, and record review, the agency failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) in order to assess the agency’s processes of care, services, and operations, from January 1, 2022, to May 10, 2023, in a universe of 50 patients. (Refer to G 642) 2. Based on interview, and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2022, to May 10, 2023, in a universe of 50 patients. (Refer to G 644) 3. Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2022, to May 10, 2023, in a universe of 50 patients. (Refer to G 658) 4. Based on interview, and record review, the agency’s Governing Body (GB) failed to provide oversight for its Quality Assessment and Performance Improvement (QAPI) Program from January 1, 2022, to May 10, 2023, in a universe of 50 patients when: a. The QAPI program failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) from January 1, 2022, to May 10, 2023, in order to assess the agency’s processes of care, services, and operations. (Refer to G 660) b. The QAPI program failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services from January 1, 2022, to May 10, 2023. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection from January 1, 2022, to May 10, 2023. (Refer to G 660) c. The QAPI program failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) from January 1, 2022, to May 10, 2023, the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved. (Refer to G 660) The cumulative effect of these systemic practices resulted in the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. And the potential for the agency to provide inferior care and services to its patients.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) in order to assess the agency’s processes of care, services, and operations, from January 1, 2022, to May 10, 2023, in a universe of 50 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. The QAPI binder did not contain data collection but indicated the following quality indicators: a. Fall Risk Assessment b. Medication Reconciliation c. Infection Control Monitoring d. Business Operations The QAPI binder did not contain documented evidence to show data had been collected, assembled and analyzed, from January 1, 2022, to May 10, 2023. There was no documented evidence to show statistical techniques such as controls charts (a graph used to study how a process changes over time), histograms (a graphical representation that organizes a group of data points into user-specified ranges), bar graphs (a chart that plots data using rectangular bars or columns) or pareto charts (a chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line) had been used to analyze the collected data. The QAPI binder did not contain documented evidence to show the agency had developed mechanisms such as thresholds (a value), setting upper and lower control limits (identifies what value is acceptable), percentages (numbers that summarize data), ratios (the relationship in quantity, amount, or size between two or more things) or performance goals in order to identify levels, patterns or trends in the agency’s provision of care from January 1, 2022, to May 10, 2023. During a concurrent record review and interview, on May 10, 2023, at 1:42 PM, with the Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The DPCS stated she was responsible for the QAPI program. The DPCS stated the Previous Director of Patient Care Services Designee (P/DPCSD) was supposed to conduct the data collection and analysis for the QAPI program and she had not done it. The DPCS stated the P/DPCSD’s last day of work had been June 15, 2022. The DPCS stated she had not taken over or delegated the responsibility of data collection and analysis for the QAPI program from June 16, 2022, to May 10, 2023. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “…3. Creating and maintaining information systems and data management processes to support the collecting, managing and analyzing of data to improve performance 4. Utilizing appropriate statistical techniques to analyze and display data a. Statistical methodologies to consider include: 1. Run charts that display summary comparison data. 2. Scatter diagrams. 3. Control charts that display variation and trends over time. 4. Histograms. 5. Pareto charts. 6. Cause and effect or fishbone diagrams. 7. Process flowcharts. J. Assure that each performance improvement activity contains the following elements: 1. Description of the indicator(s)/activities to be conducted. 2. Frequency of activities. 3. Designation of responsible party. 4. Method(s) of data collection. 5. Acceptable limits for findings. 6. Who will receive the report. 7. Follow-up plans if findings fail to meet acceptable limits including plan(s) of correction. …”

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection, from January 1, 2022, to May 10, 2023, in a universe of 50 patients. This failure had the potential for the agency to miss statistically significant data from OASIS reports and fail to identify patient population trends. In addition, the GB may miss an opportunity to correct ineffective data collection. 1. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. The QAPI binder did not contain data collection but indicated the following quality indicators: a. Fall Risk Assessment b. Medication Reconciliation c. Infection Control Monitoring d. Business Operations The QAPI binder did not contain documented evidence to show a quality indicator had been chosen for the time period of: January 1, 2022, to May 10, 2023, from the following OASIS reports: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a "snapshot" of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During a concurrent record review and interview, on May 10, 2023, at 2:30 PM, with the Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The DPCS stated she was responsible for the QAPI program. The DPCS verified a quality indicator had not been chosen from the OASIS reports. The DPCS stated she had been unaware of this requirement. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “… E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings. …1. At least one important aspect related to care must be monitored through use of OASIS data. 2. At least one important administrative aspect of function or service care must be monitored. 3. Monitor indicators related to improved outcomes including the use of emergent care services, hospital admissions and re-admissions, and takes actions that address performance across the spectrum of care, including the prevention and reduction of medical errors. …” 2. A review of the agency's "Governing Body Minutes," binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. There was no documented evidence to show the Governing Body (GB) approved the frequency and detail of the QAPI program’s data collection. There was no documented evidence to show the QAPI Committee had provided the detail and frequency of data collection to the GB for review and approval. During an interview with the Director of Patient Care Services (DPCS), on May 10, 2023, at 2:30 PM, the DPCS stated she had not provided the GB the frequency and detail of the QAPI program’s data collection from January 1, 2022, to May 10, 2023. The DPCS stated she was a member of the Governing Body (GB) and the GB had not approved the frequency and detail of data collection for the QAPI program from January 1, 2022, to May 10, 2023. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually.”

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2022, to May 10, 2023, in a universe of 50 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care to go unaddressed and continue. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 17 months (January 1, 2022, to May 10, 2023) reviewed. During a concurrent record review and interview, on May 10, 2023, at 3:15 PM, with the Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The DPCS stated she was responsible for the QAPI program. The DPCS stated the Previous Director of Patient Care Services Designee (P/DPCSD) was supposed to conduct the performance improvement projects and she had not done it. The DPCS stated the P/DPCSD’s last day of work had been June 15, 2022. The DPCS stated she had not taken over or delegated the responsibility of conducting the performance improvement projects for the QAPI program from June 16, 2022, to May 10, 2023. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “…H. Ensure that performance improvement projects are conducted that reflect the following standards: 1. The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the organization's services and operations. 2. The organization must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. …”

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency’s Governing Body (GB) failed to provide oversight for its Quality Assessment and Performance Improvement (QAPI) Program from January 1, 2022, to May 10, 2023, in a universe of 50 patients when: 1. The QAPI program failed to measure and analyze quality indicators (a measurable element of the agency’s practice that can be used to assess the quality of care provided) from January 1, 2022, to May 10, 2023, in order to assess the agency’s processes of care, services, and operations. 2. The QAPI program failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services from January 1, 2022, to May 10, 2023. In addition, the agency’s Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program’s data collection from January 1, 2022, to May 10, 2023. 3. The QAPI program failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) from January 1, 2022, to May 10, 2023, the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved. This failure had the potential to cause the agency to provide inferior care and services to its patients. 1. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. The QAPI binder did not contain data collection but indicated the following quality indicators: a. Fall Risk Assessment b. Medication Reconciliation c. Infection Control Monitoring d. Business Operations The QAPI binder did not contain documented evidence to show data had been collected, assembled and analyzed, from January 1, 2022, to May 10, 2023. There was no documented evidence to show statistical techniques such as controls charts (a graph used to study how a process changes over time), histograms (a graphical representation that organizes a group of data points into user-specified ranges), bar graphs (a chart that plots data using rectangular bars or columns) or pareto charts (a chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line) had been used to analyze the collected data. The QAPI binder did not contain documented evidence to show the agency had developed mechanisms such as thresholds (a value), setting upper and lower control limits (identifies what value is acceptable), percentages (numbers that summarize data), ratios (the relationship in quantity, amount, or size between two or more things) or performance goals in order to identify levels, patterns or trends in the agency’s provision of care from January 1, 2022, to May 10, 2023. During a concurrent record review and interview, on May 10, 2023, at 1:42 PM, with the Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The DPCS stated she was responsible for the QAPI program. The DPCS stated the Previous Director of Patient Care Services Designee (P/DPCSD) was supposed to conduct the data collection and analysis for the QAPI program and she had not done it. The DPCS stated the P/DPCSD’s last day of work had been June 15, 2022. The DPCS stated she had not taken over or delegated the responsibility of data collection and analysis for the QAPI program from June 16, 2022, to May 10, 2023. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “…3. Creating and maintaining information systems and data management processes to support the collecting, managing and analyzing of data to improve performance 4. Utilizing appropriate statistical techniques to analyze and display data a. Statistical methodologies to consider include: 1. Run charts that display summary comparison data. 2. Scatter diagrams. 3. Control charts that display variation and trends over time. 4. Histograms. 5. Pareto charts. 6. Cause and effect or fishbone diagrams. 7. Process flowcharts. J. Assure that each performance improvement activity contains the following elements: 1. Description of the indicator(s)/activities to be conducted. 2. Frequency of activities. 3. Designation of responsible party. 4. Method(s) of data collection. 5. Acceptable limits for findings. 6. Who will receive the report. 7. Follow-up plans if findings fail to meet acceptable limits including plan(s) of correction. …” 2a. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. The QAPI binder did not contain data collection but indicated the following quality indicators: a. Fall Risk Assessment b. Medication Reconciliation c. Infection Control Monitoring d. Business Operations The QAPI binder did not contain documented evidence to show a quality indicator had been chosen for the time period of: January 1, 2022, to May 10, 2023, from the following OASIS reports: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a "snapshot" of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During a concurrent record review and interview, on May 10, 2023, at 2:30 PM, with the Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The DPCS stated she was responsible for the QAPI program. The DPCS verified a quality indicator had not been chosen from the OASIS reports. The DPCS stated she had been unaware of this requirement. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “… E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings. …1. At least one important aspect related to care must be monitored through use of OASIS data. 2. At least one important administrative aspect of function or service care must be monitored. 3. Monitor indicators related to improved outcomes including the use of emergent care services, hospital admissions and re-admissions, and takes actions that address performance across the spectrum of care, including the prevention and reduction of medical errors. …” 2b. A review of the agency's "Governing Body Minutes," binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. There was no documented evidence to show the Governing Body (GB) approved the frequency and detail of the QAPI program’s data collection. There was no documented evidence to show the QAPI Committee had provided the detail and frequency of data collection to the GB for review and approval. During an interview with the Director of Patient Care Services (DPCS), on May 10, 2023, at 2:30 PM, the DPCS stated she had not provided the GB the frequency and detail of the QAPI program’s data collection from January 1, 2022, to May 10, 2023. The DPCS stated she was a member of the Governing Body (GB) and the GB had not approved the frequency and detail of data collection for the QAPI program from January 1, 2022, to May 10, 2023. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually.” 3. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 17 months (January 1, 2022, to May 10, 2023) reviewed. During a concurrent record review and interview, on May 10, 2023, at 3:15 PM, with the Director of Patient Care Services (DPCS) the contents of the QAPI binder were reviewed. The DPCS stated she was responsible for the QAPI program. The DPCS stated the Previous Director of Patient Care Services Designee (P/DPCSD) was supposed to conduct the performance improvement projects and she had not done it. The DPCS stated the P/DPCSD’s last day of work had been June 15, 2022. The DPCS stated she had not taken over or delegated the responsibility of conducting the performance improvement projects for the QAPI program from June 16, 2022, to May 10, 2023. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “…H. Ensure that performance improvement projects are conducted that reflect the following standards: 1. The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the organization's services and operations. 2. The organization must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. …” A review of the agency's "Governing Body Minutes," binder, dated 2022 to 2023, was conducted from January 1, 2022, to May 10, 2023. There was no documented evidence to show the Governing Body (GB) had received a written report from the QAPI Coordinator that included a summary of all activities included as part of the QAPI Plan. There was no documented evidence to show the QAPI Coordinator had provided the detail and frequency of data collection to the GB for review and approval. There was no documented evidence to show the GB approved the frequency and detail of the QAPI program’s data collection. The was no documented evidence to show the GB identified the QAPI committee’s failure to measure and analyze data, chose a quality indicator from OASIS reports or conduct performance improvement projects. During an interview with the Administrator (Admin) and the Director of Patient Care Services (DPCS) on May 10, 2023, at 3:15 PM, the DPCS stated she had not provided the GB a written report that included a summary of all activities included as part of the QAPI Plan or provided the detail and frequency of data collection from January 1, 2022, to May 10, 2023, to the GB for review and approval. The Admin and DPCS stated they were both members of the GB. The Admin and DPCS stated the GB had not identified the QAPI committee’s failure to measure and analyze data, chose a quality indicator from OASIS reports or conduct performance improvement projects from January 1, 2022, to May 10, 2023. The Admin and DPCS stated the GB had not approved the frequency and detail of the QAPI program’s data collection from January 1, 2022, to May 10, 2023. A review of the agency’s policy and procedure titled, “Improving Organizational Performance,” dated April 2020, indicated, “POLICY: Senior management will have the responsibility: to guide the organization's efforts in improving organizational performance; to define expectations of the performance improvement activities; and to generate the plan and processes the organization will utilize to assess, improve and maintain quality of care and service. Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications. All personnel will be active participants in the organization's performance improvement activities. The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually. … 4. Trends identified through performance improvement measurement and analysis will be reported to the Governing Body on a quarterly basis.”

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to ensure a Physical Therapist (PT) evaluated and created a care plan that included visit frequencies for one of seven sampled patients (Patient 6). This failure caused the agency to provide care that was not care planned or approved by a physician. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of January 12, 2023, with a certification period of January 12, 2023, to March 12, 2023. Patient 6 had diagnoses that included pressure ulcer (a sore caused by prolonged pressure). A review of Patient 6’s “Physical Therapy Evaluation,” dated January 20, 2023, was conducted. There was no documented evidence to show the PT had made visit frequency recommendations. A review of Patient 6’s physician’s orders from January 20, 2023, to May 8, 2023, was conducted. There was no documented evidence to show a physician’s order for PT visit frequencies. A review of Patient 6’s PT visit notes from January 20, 2023, to May 8, 2023, indicated a PT visited Patient 6 on January 24, 2023, and January 26, 2023. (Two PT visits were made without a physician’s order) During an interview with the Director of Patient Care Services (DPCS) on May 8, 2023, at 10:30 AM, the DPCS verified the PT had not evaluated and care planned visit frequencies for Patient 6. The DPCS verified there were no physician’s orders for PT visit frequencies and the PT visited Patient 6 without a physician’s order. A review of the agency’s policy and procedure titled “Scope of Services,” dated April 2020, indicated, “…6. Rehabilitative therapies are provided according to the patient's plan of care by a registered/certified physical or occupational therapist in accordance with the patient's plan of care and include A. Initial and ongoing assessments to determine the level of functioning, including OASIS assessments at appropriate points in time. B. Developing and revising the plan of care in consultation with the physician and other care team members. C. Goal setting. D. Providing therapeutic treatments. …H. Coordinating services in consultation with home health staff. …” A review of the agency’s policy and procedure titled, “Admission Criteria and Process,” dated April 2020, indicated, “…The patient must be under the care of a physician. The patient’s physician (or other authorized licensed independent practitioner) must order and approve the provision of any service. A skilled service must be ordered.”

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to follow physician’s orders documented on the CMS 485 (a form provided by the Centers for Medicare and Medicaid Services-CMS-which documents a patient’s plan of care and physician’s orders) for two of seven sampled patients (Patients 2 and 3) when: 1. For Patient 2, five Physical Therapy (PT) visits were not made as ordered. 2. For Patient 3, one Physical Therapy (PT) visits was not made as ordered. This failure had the potential to cause Patients 2 and 3 to suffer a delay in achieving their physical therapy goals 1. A review of Patient 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of March 31, 2023, with a certification period of March 31, 2023, to May 29, 2023. Patient 2 had diagnoses that included acute kidney failure (a condition in which the kidneys suddenly cannot filter waste from the blood). A review of Patient 2’s CMS 485 dated March 31, 2023 to May 29, 2023, indicated the physical therapist (PT) was to make visits to Patient 2, two times a week for four weeks. A review of Patient 2’s PT visit notes for recertification period March 31, 2023 to May 29, 2023, was conducted. The PT visit notes indicated the following visits were made: a. April 2, 2023, to April 8, 2023, two PT visits were ordered, two PT visits were made. b. April 9, 2023, to April 15, 2023, two PT visits were ordered, one PT visits was made. c. April 16, 2023, to April 22, 2023, two PT visits were ordered, zero PT visits were made. d. April 23, 2023, to April 29, 2023, two PT visits were ordered, zero PT visits were made. During an interview with the Case Manager/Intake (CM/I) and the Director of Patient Care Services (DPCS) on May 10, 2023, at 9:25 AM, the CM/I stated PT scheduled their own visits and the scheduled visits had been missed. The CM/I stated PT had not followed the agency’s policy and procedure titled “Missed Visits,” dated April 2020, and PT was required to follow the agency’s policies and procedures. The DPCS stated the home health agency should have ensured PT made visits to their patients as ordered and followed the agency’s policies and procedures. 2. A review of Patient 3’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of April 12, 2023, with a certification period of April 12, 2023, to June 10, 2023. Patient 3 had diagnoses that included diabetes mellitus (a disease that causes high blood sugar levels). A review of Patient 3’s CMS 485 dated April 12, 2023 to June 10, 2023, indicated the physical therapist (PT) was to make visits to Patient 3, one time a week for four weeks. A review of Patient 3’s PT visit notes for recertification period April 12, 2023 to June 10, 2023, was conducted. The PT visit notes indicated the following visits were made: a. April 9, 2023, to April 15, 2023, one PT visits was ordered, one PT visits was made. b. April 16, 2023, to April 22, 2023, one PT visit was ordered, one PT visit was made. c. April 23, 2023, to April 29, 2023, one PT visit was ordered, one PT visit was made. d. April 30, 2023, to May 6, 2023, one PT visit was ordered, zero PT visits were made. During an interview with the Case Manager/Intake (CM/I) on May 11, 2023, at 12:30 PM, the CM/I stated PT scheduled their own visits and the scheduled visits had been missed. The CM/I stated PT had not followed the agency’s policy and procedure titled “Missed Visits,” dated April 2020 and PT was required to follow the agency’s policies and procedures. The CM/I stated she should have ensured PT made visits to their patients as ordered and followed the agency’s policies and procedures. A review of the agency’s policy and procedure titled, “Missed Visit,” dated, revised, April 2020, indicated, “Policy. Missed visits will be communicated to the clinical supervisor and the patient’s physician. A missed visit will be rescheduled the same week if possible. Missed visits will be documented in the clinical record. Procedure. 1. If a visit is missed for any reason, the clinician should attempt to reschedule it for the same week so that the physician-ordered frequency is maintained and would not be considered a missed visit. 2. If a visit is missed and not rescheduled the clinician will: A. Notify the physician and clinical supervisor of the missed visit and reason for missed visit. B. Document in the patient's clinical record the following information: 1. Patient name. 2. Date and type of visit that was missed. 3. Reason for the missed visit. 4. Description of any unmet needs and how the patient's needs were met. 5. Physician notification including date, time, physician name, method of notification and the staff reporting the information. 6. Any other follow-up needed. 7. Other person(s) that were notified of the missed visit. 8. Signature of staff member reporting the information. …”

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to ensure a Registered Nurse (RN) provided supervision of care provided by a Licensed Vocational Nurse (LVN) for three of seven sampled patients (Patient 1, 2, and 6). This failure had the potential to cause substandard LVN care practices to go unrecognized and unaddressed. 1. A review of Patient 1’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of February 10, 2023, with a recertification period of April 11, 2023, to June 9, 2023. Patient 1 had diagnoses that included polyosteoarthritis (a disease that causes pain and inflammation in five or more joints). A review of Patient 1’s CMS 485 (a form provided by the Centers for Medicare and Medicaid Services-CMS-which documents a patient’s plan of care and physician’s orders) dated April 11, 2023, to June 9, 2023, indicated, the skilled nurse (SN- a Registered Nurse-RN or a Licensed Vocational Nurse-LVN) was to make visits to Patient 1, two times a week for one week, and one time a week for seven weeks. A review of Patient 1’s LVN visit notes indicated visits were made on April 11, 2023, April 14, 2023, April 21, 2023, April 28, 2023, and May 5, 2023. A review of Patient 1’s RN visit notes from April 11, 2023, to May 11, 2023, was conducted. There was no documented evidence to show an RN supervisory visit for the LVN had been conducted. During an interview with the Director of Patient Care Services (DPCS) May 11. 2023, at 12:00 PM, the DPCS stated an RN was supposed to conduct a supervisory visit for the LVN every 30 days. The DPCS stated the LVN that visited Patient 1 had not received a supervisory visit within the 30-day time period and should have. 2. A review of Patient 2’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of March 31, 2023, with a certification period of March 31, 2023, to May 29, 2023. Patient 2 had diagnoses that included acute kidney failure (a condition in which the kidneys suddenly cannot filter waste from the blood). A review of Patient 2’s CMS 485 (a form provided by the Centers for Medicare and Medicaid Services-CMS-which documents a patient’s plan of care and physician’s orders), dated March 31, 2023, to May 29, 2023, indicated, the skilled nurse (SN- a Registered Nurse-RN or a Licensed Vocational Nurse-LVN) was to make visits to Patient 2, one time a week for one week, two times a week for two weeks, and one time a week for six weeks. A review of Patient 2’s LVN visit notes indicated visits were made on March 31, 2023, April 4, 2023, April 6, 2023, April 13, 2023, April 24, 2023, and May 1, 2023. A review of Patient 2’s RN visit notes from March 31, 2023, to May 10, 2023, was conducted. There was no documented evidence to show an RN supervisory visit for the LVN had been conducted. During an interview with the Director of Patient Care Services (DPCS) May 10. 2023, at 9:15 AM, the DPCS stated an RN was supposed to conduct a supervisory visit for the LVN every 30 days. The DPCS stated the LVN that visited Patient 2 had not received a supervisory visit within the 30-day time period and should have. 3. A review of Patient 6’s plan of care (a document that provides direction on the type of clinical care a patient needs), undated, indicated a start of care date of January 12, 2023, with a certification period of January 12, 2023, to March 12, 2023. Patient 6 had diagnoses that included pressure ulcer (a sore caused by prolonged pressure). A review of Patient 6’s CMS 485 (a form provided by the Centers for Medicare and Medicaid Services-CMS-which documents a patient’s plan of care and physician’s orders), dated January 12, 2023, to May March 12, 2023, indicated, the skilled nurse (SN- a Registered Nurse-RN or a Licensed Vocational Nurse-LVN) was to make visits to Patient 6, one time a week for one week, and two times a week for four weeks. A review of Patient 6’s LVN visit notes indicated visits were made on January 16, 2023, January 24, 2023, January 26, 2023, February 14 2023, and February 28, 2023. A review of Patient 6’s RN visit notes from January 12, 2023, to March 9, 2023, was conducted. There was no documented evidence to show an RN supervisory visit for the LVN had been conducted. During an interview with the Director of Patient Care Services (DPCS) May 8. 2023, at 10:40 AM, the DPCS stated an RN was supposed to conduct a supervisory visit for the LVN every 30 days. The DPCS stated the LVN that visited Patient 6 had not received a supervisory visit within the 30-day time period and should have. A review of the agency’s policy and procedure titled, “Responsibilities/Supervision of Clinical Services,” dated, revised, November 2017, indicated, “…B. Licensed practical/vocational nurses [LPN/LVN] will be supervised by a registered nurse making a visit to the home with or without the LPN/LVN every thirty (30) days unless state regulation requires more frequently.”

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on interview, and record review, the Governing Body (GB) failed to operate and manage the agency from January 1, 2022, to May 11, 2023, in a universe of 50 patients when: 1. A current California State License was not maintained (expiration date June 2, 2021). 2. A current California Department of Public Health (CDPH) Laboratory Registration was not maintained (expiration date October 4, 2018). 3. A current Clinical Laboratory Improvement Amendments of 1988 (CLIA- federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States) was not maintained (expiration date October 6, 2022). 4. A qualified Director of Patient Care Services Designee (DPCSD) was not available to assume oversight of clinical personnel and responsibilities of patient care services in the absence of the Director of Patient Care Services (DPCS). These failures caused the agency to conduct business without a State License for 23 months, perform waived laboratory testing without CDPH oversight for four years and seven months, and perform waived laboratory testing without Federal oversight for seven months. In addition, these failures had the potential to cause the absence of a Director of Patient Care Services to direct the agency’s clinical personnel and patient care services for 11 months. 1. During an agency tour on May 8, 2023, at 10:15 AM, a California State License for the agency was posted on the front office wall. The California State License indicated an expiration date of June 2, 2021. During an interview with the Administrator (Admin) on March 8, 2023, at 10:25 AM, the Admin stated he and the Director of Patient Care Services (DPCS) were members of the agency’s Governing Body (GB) and it was his responsibility to ensure the agency’s license was kept current and active. The Admin stated he had not renewed the agency’s California State License. The Admin stated the agency had been conducting business without a current State License for 23 months. 2. During an agency tour on May 8, 2023, at 10:15 AM, a California Department of Public Health (CDPH) Laboratory Registration, for the agency, was posted on the front office wall. The CDPH Laboratory Registration indicated an expiration date of October 4, 2018. During an interview with the Administrator (Admin) and Director of Patient Care Services (DPCS) on March 8, 2023, at 10:25 AM, the Admin stated he and the DPCS were members of the agency’s Governing Body (GB) and it was his responsibility to ensure the agency’s CDPH Laboratory Registration was kept current and active. The Admin stated he had not renewed the California Department of Public Health (CDPH) Laboratory Registration. The Admin and DPCS stated the agency had been conducting waived laboratory testing without a current CDPH Laboratory Registration for four years and seven months. 3. During an agency tour on May 8, 2023, at 10:15 AM, a Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the agency, was posted on the front office wall. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) indicated an expiration date of October 6, 2022. During an interview with the Administrator (Admin) and Director of Patient Care Services (DPCS) on March 8, 2023, at 10:25 AM, the Admin stated he and the DPCS were members of the agency’s Governing Body (GB) and it was his responsibility to ensure the agency’s Clinical Laboratory Improvement Amendments of 1988 (CLIA) was kept current and active. The Admin stated he had not renewed the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The Admin and DPCS stated the agency had been conducting waived laboratory testing without a current Clinical Laboratory Improvement Amendments of 1988 (CLIA) for seven months. 4. A review of the agency’s “Organizational Chart,” undated, was conducted. There was no documented evidence to show current employment of a Director of Patient Care Services Designee (DPCSD). During an interview with the Administrator (Admin) and Director of Patient Care Services (DPCS) on May 8, 2023, at 11:32 AM, the Admin verified he and the DPCS were members of the agency’s Governing Body (GB). The Admin and DPCS stated they did not have a DPCSD at this time. The DPCS stated the previous DPCSD quit, and they had not been successful in hiring a new one. The DPCS stated the previous DPCSD’s last day of work was June 15, 2022. The DPCS stated she had talked to the one Registered Nurse (RN) on staff about covering the position, but she declined the offer. The Admin and DPCS verified the agency had been operating without a DPCSD for approximately 11 months. A review of the agency’s policy and procedure titled, “Regulatory Compliance,” dated April 2020, indicated, “PURPOSE: To ensure compliance with local, state, federal, and other regulatory bodies. POLICY: The organization will maintain evidence of regulatory compliance, including but not limited to 1. Current state license, 2. Organization…policies and procedures, 3. Medicare and Medicaid provider numbers and regulations, 4. Business and occupational licenses for city, county as required, 5. CLIA certification …12. Public Health regulations relating to infectious disease, 13. Professional standards and principles, A. Federal regulations, B. State practice acts, C. Commonly accepted health standards established by national organizations, boards, and councils.” A review of the agency’s policy and procedure titled, “Responsibilities/Supervision of Clinical Services,” dated November 2017, indicated, “PURPOSE: To define the process for supervision of clinical services provided by [Name of agency]. POLICY: Nursing and home health aide services will be under the supervision of a registered nurse who has at least two (2) years of home or community-based health care experience. Supervision of clinical care and services will be available 24 hours a day, seven (7) days a week. Supervisor-to-patient care personnel ratios will depend on the acuity level of the patients and case mix and be in compliance with applicable law or regulation. The Clinical Director will be responsible for the clinical direction of the organization and take reasonable steps to assure that: 1. Services are available. 2. Care and services provided by organization personnel and contracted organization personnel are coordinated and integrated. 3. Policies and procedures, which guide and support the provision of care and services, are developed and implemented. 4. Recommendations for required resources are made.” A review of the agency’s policy and procedure titled, “Governing Body,” dated April 2020, indicated, “PURPOSE: To outline the roles and responsibilities of the Governing Body. POLICY: The Governing Body will assume full legal authority, responsibility, decision-making and accountability for the overall management and operations, the provision of services, fiscal operations, human resource management, review of the organization's budget and operational plans, and its quality assessment and performance improvement (QAPI) program. The Governing Body of [name of agency] will serve as the governing authority for the home care program, which will function according to [name of agency] bylaws.”